Gebrauchshinweis
SARSTEDT Salivette® Cortisol

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DE Gebrauchshinweis – SARSTEDT Salivette® Cortisol
EN Instructions for use – SARSTEDT Salivette® Cortisol
BG ȤɉɍɎɌɏɆɒɄɄɃȼɏɋɊɎɌɁȽȼş6$567('76DOLYHWWH® Cortisol
CS Návod k obsluze – SARSTEDT Salivette® Cortisol
DA Brugsanvisning – SARSTEDT Salivette® Cortisol
EL 2ǳǶǲǮǴǿȄǾǭȀǴȆǿş6$567('76DOLYHWWH® Cortisol
ES Instrucciones de uso – SARSTEDT Salivette® Cortisol
ET Kasutusjuhend – SARSTEDT Salivette® Cortisol
FR Mode d’emploi – SARSTEDT Salivette® Cortisol
HR Uputa za upotrebu – SARSTEDT Salivette® Cortisol
HU Használati utasítás – SARSTEDT Salivette® Cortisol
Istruzioni d’uso – SARSTEDT Salivette® CortisolIT
KO ㌂㣿G㍺ⳛ㍲ – SARSTEDT Salivette® Cortisol
LT Naudojimo instrukcijos – SARSTEDT Salivette® Cortisol
LV /LHWRđDQDVQRUÌGHVş6$567('76DOLYHWWH® Cortisol
NL Gebruiksaanwijzing – SARSTEDT Salivette® Cortisol
NO Bruksanvisning – SARSTEDT Salivette® Cortisol
PL ,QVWUXNFMDREVúXJLş6$567('76DOLYHWWH® Cortisol
PT Instruções de utilização – SARSTEDT Salivette® Cortisol
RO ,QVWUXFėLXQLGHXWLOL]DUHş6$567('76DOLYHWWH® Cortisol
RU ȤɉɍɎɌɏɆɒɄɛɋɊɋɌɄɈɁɉɁɉɄɚş6$567('76DOLYHWWH® Cortisol
SK 1ÈYRGQDSRXĭLWLHş6$567('76DOLYHWWH® Cortisol
SL Navodila za uporabo – SARSTEDT Salivette® Cortisol
SV Bruksanvisning – SARSTEDT Salivette® Cortisol
TH คําแนะนําในการใช้งาน – SARSTEDT Salivette® Cortisol
TR .XOODQêPL×LQWDOLPDWODUş6$567('76DOLYHWWH® Cortisol
ZH ἗䓀完㖦 – SARSTEDT Salivette® Cortisol

1Gebrauchshinweis – SARSTEDT Salivette® Cortisol

DE

Verwendungszweck
Die Salivette® Cortisol ist ein Probengefäß für Speichelproben und dient der Entnahme, dem Transport, der Verarbeitung und der Lagerung von Speichel für die in-vitro diagnostische Bestimmung von Cortisol. Das
Produkt ist für den Einsatz im professionellen Umfeld und die Anwendung durch medizinisches Fachpersonal und Laborpersonal bestimmt.

Produktbeschreibung
Die Salivette® Cortisol besteht aus einem transparenten Kunststoffgefäß mit Spitzboden, einem Einhängegefäß, einer Saugrolle und einem blauen Stopfen.

51.1534.500=

Kunststoffgefäß+

Einhängegefäß+

Saugrolle+

blauer Stopfen

Sicherheits- und Warnhinweise1.

Das Produkt darf nicht bei Kindern unter 3 Jahren sowie bei Patienten mit erhöhter Verschluckungsgefahr angewendet werden.

2.

Allgemeine Vorsichtsmaßnahmen: Verwenden Sie Handschuhe und andere allgemeine persönliche Schutzausrüstung, um sich vor einer möglichen Exposition gegenüber potentiell infektiösem Probenmaterial zu
schützen. Die Sicherheitsrichtlinien und -verfahren Ihrer Einrichtung müssen befolgt werden.

3.

Der mit der Salivette® Cortisol gewonnene und verarbeitete Speichel ist nicht zur Rückführung in den menschlichen Körper bestimmt.

4.

Eine Salivette® Cortisol nach dem Haltbarkeitsdatum nicht mehr verwenden. Die Haltbarkeit einer Salivette® Cortisol endet am letzten Tag des angegebenen Monats und Jahres.

Lagerung
Die Salivette® Cortisol ist vor Verwendung bei Raumtemperatur zu lagern.

Transport
Das Produkt kann manuell innerbetrieblich oder zusammen mit einem ADR (Verpackungsanweisung P650) konformen Sekundärgefäß transportiert werden. Für den Probentransport der Salivette® Cortisol wird das ADR(Verpackungsanweisung P650) konforme Versandgefäß Art.-Nr. 78.898 mit Saugeinlage plus Schraubverschluss Art.-Nr. 65.679 sowie eine Versandbox /-tasche empfohlen.
Für Patient:
Folgen Sie zur Rückgabe der Speichelprobe in der fest verschlossenen Salivette® Cortisol den Anweisungen des Arztes und verwenden Sie das vom Arzt bereitgestellte Sekundärgefäß und die Versandbox /-tüte. Falls
die Rückgabe nicht direkt erfolgt, lagern Sie diese Salivette® Cortisol im Kühlschrank.

Einschränkungen
Die Speichelentnahme soll frühestens 60 Minuten nach einer Mahlzeit (flüssige/feste Nahrungsaufnahme), Zähneputzen oder oralen Einnahme von Medikamenten erfolgen, um eine Kontamination des Speichels durch
störende Substanzen zu vermeiden.
Lagerungsdauer und -temperatur sind abhängig von der Haltbarkeit der zu untersuchenden Parameter. Daher und auf Grund des schon bei Raumtemperatur nach einigen Stunden einsetzenden Bakterienwachstums im
Speichel wird empfohlen, die Salivette® Cortisol nach Probennahme fest verschlossen entweder innerhalb von 4h zu zentrifugieren und zu analysieren oder direkt im Kühlschrank bis zur weiteren Prozessierung zu lagern.

Probennahme und Handhabung
LESEN SIE DIESES DOKUMENT VOLLSTÄNDIG DURCH, BEVOR SIE MIT DER SPEICHELGEWINNUNG BEGINNEN.
Für die Probennahme benötigtes Arbeitsmaterial:
1.

Handschuhe, Kittel, Augenschutz oder andere geeignete Schutzkleidung zum Schutz vor durch Speichel übertragene Pathogene oder potenziell infektiösen Materialien.

2.

Anzahl Salivette® Cortisol gemäß Anforderung vom Arzt.

3.

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2

DE
Probennahme- 60 min

- 50

- 40

- 30

- 20

- 10 min

0

2 min ohne
Kaubewegung
1-5 secHƴO

2 min
1.000 x g

Probe

Rückstände

Die Speichelentnahme soll frühestens 60 Minuten nach einer Mahlzeit (flüssige/feste Nahrungsaufnahme), Zähneputzen oder oralen Einnahme von Medikamenten erfolgen, um eine Kontamination des Speichels
durch störende Substanzen zu vermeiden. Bis 10 Minuten vor Probennahme den Mund für 1-5 Sekunden mit Wasser spülen.
Unmittelbar vor der Speichelentnahme Hände waschen und abtrocknen.
Die Saugrolle am hinteren Ende mit zwei Fingern aus der geöffneten Salivette® Cortisol entnehmen und
in den Mund legen.
Die Saugrolle soll für 2 Minuten ohne Kaubewegungen im Mund (z.B. Wangentasche) verweilen. Die zu gewinnende Mindestspeichelmenge soll 500μl betragen. Bei extrem geringer Speichelbildung lässt man die
Saugrolle länger im Mund ruhen.
Die Saugrolle am hinteren Ende mit zwei Fingern aus dem Mund nehmen undunmittelbar in die Salivette® Cortisol stecken und mit dem blauen Stopfen verschließen.
Für Patient: Folgen Sie zur Rückgabe der Speichelprobe in der fest verschlossenen Salivette® Cortisol den Anweisungen des Arztes und verwenden Sie das vom Arzt bereitgestellte Sekundärgefäß und die
Versandbox /-tüte. Falls die Rückgabe nicht direkt erfolgt, lagern Sie diese Salivette® Cortisol im Kühlschrank.
Für Arzt und Labor:
Auf Grund des schon bei RT nach einigen Stunden einsetzenden Bakterienwachstums im Speichel wird empfohlen, die Salivette® Cortisol nach Probennahme fest verschlossen entweder innerhalb von 4h bei
1.000 x g für 2 Minuten zu zentrifugieren und zu analysieren oder direkt im Kühlschrank bis zur weiteren Prozessierung zu lagern.
Nach Zentrifugation das Einhängegefäß inklusive Stopfen aus dem Kunststoffgefäß mit Spitzboden herausnehmen.
Im Spitzboden des Kunststoffgefäßes befindet sich der reine Speichel für die weitere Analyse über den Rückständen, die sich im Reservoir des Spitzbodens befinden.
Nach Analyse das Kunststoffgefäß mit Spitzboden und das Einhängegefäß in einem Entsorgungsbehälter entsorgen.

Entsorgung – gilt für Arzt und Labor
1.

Es sind die allgemeinen Hygienerichtlinien sowie die gesetzlichen Bestimmungen für die ordnungsgemäße Entsorgung von infektiösem Material zu beachten und einzuhalten.

2.

Einmalhandschuhe verhindern dabei das Risiko einer Infektion.

3.

Kontaminierte oder befüllte Salivette®&RUWLVROPXVVLQJHHLJQHWHP(QWVRUJXQJVEHKËOWHUIĞUELRORJLVFKH*HIDKUVWRĳHHQWVRUJWZHUGHQGHUDQVFKOLHĔHQGDXWRNODYLHUWXQGYHUEUDQQWZHUGHQNDQQ

4.

Die Entsorgung muss in einer geeigneten Verbrennungsanlage oder mittels Autoklavieren (Dampfsterilisation) erfolgen.

3

DE
Literatur
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Symbol- und Kennzeichnungsschlüssel:

Artikelnummer

Chargenbezeichnung

Verwendbar bis

CE-Zeichen

In-vitro-Diagnostikum

Gebrauchsanleitung beachten

Bei Wiederverwendung: Kontaminationsgefahr

Vor Sonnenlicht geschützt aufbewahren

Trocken lagern

Hersteller

Land der Herstellung

Technische Änderungen vorbehalten.
Alle in Zusammenhang mit dem Produkt aufgetretenen schwerwiegenden Vorfälle sind dem Hersteller und der zuständigen nationalen Behörde zu melden.

4Instructions for use – SARSTEDT Salivette® Cortisol

EN

Intended use
The Salivette® Cortisol is a specimen tube for saliva samples and is used for the collection, transport, processing and storage of saliva for in vitro diagnostic determination of cortisol. The product is intended for use in a
professional environment by qualified medical and laboratory personnel.

Product description
The Salivette® Cortisol consists of a transparent conical bottom plastic tube, an insert, an absorbent roll and a blue cap.

51.1534.500=

Plastic tube+

Insert+Absorbent roll+Blue cap

Safety information and warnings
1.

The product must not be used in children under 3 years of age or in patients at increased risk of choking.

2.

General precautions: Use gloves and other general personal protective equipment to protect yourself against possible exposure to potentially infectious sample material. Always follow the safety guidelines andprocedures of your facility.

3.

The saliva collected and processed with the Salivette® Cortisol is not intended to be returned to the human body.

4.

Do not use Salivette® Cortisol after the expiry date. The expiry date of Salivette® Cortisol is the last day of the month and year as indicated.

Storage
Store Salivette® Cortisol at room temperature before use.

Transport
The product can be transported manually in-house or with an ADR-compliant (packaging instruction P650) secondary container. The ADR-compliant (packaging instruction P650) shipping container, Art. no. 78.898,
with absorbent insert plus screw cap, Art. no. 65.679, and shipping box /bag is recommended for Salivette® Cortisol specimen transport.
For the patient:
To return the saliva sample in the tightly closed Salivette® Cortisol, follow the doctor's instructions and use the secondary container provided by the doctor and the shipping box/bag. If it is not returned immediately,
store this Salivette® Cortisol in the refrigerator.

Limitations
The saliva sample should be taken at least 60 minutes after a meal (liquid/solid food intake), brushing teeth or taking oral medication, in order to avoid the saliva being contaminated with interfering substances.
The storage duration and temperature depend on the shelf life for the parameters to be tested. Therefore, and since the onset of bacterial growth in saliva can be expected after just a few hours at room temperature, it isrecommended that the Salivette® Cortisol be sealed tightly after sampling and either centrifuged and analysed within 4 hours or placed immediately in a refrigerator until further processing.

Specimen collection and handling
READ ALL OF THIS DOCUMENT BEFORE STARTING TO COLLECT SALIVA.
Material required to collect a specimen:
1.

Gloves, gown, goggles or other suitable protective gear to protect against pathogens transmitted via saliva or potentially infectious materials.

2.

Number of Salivette® Cortisol tubes as requested by the doctor.

3.

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5

EN
Sample collection- 60 min

- 50

- 40

- 30

- 20

- 10 min

0

2 min without making
any chewing motions
1-5 secHƴO

2 min
1,000 x g

Specimen

Residues

The saliva sample should be taken at least 60 minutes after a meal (liquid/solid food intake), brushing teeth or taking oral medication, in order to avoid the saliva being contaminated with interfering substances.
Up to 10 minutes before taking the sample, rinse mouth with water for 1-5 seconds.
Immediately before collecting the saliva, wash and dry hands.
With two fingers, remove the absorbent roll at the far end from the opened Salivette® Cortisol andplace it in the mouth.
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the absorbent roll in the mouth longer.
With two fingers, take the absorbent roll out of the mouth by the far end andplace it immediately in the Salivette® Cortisol and seal with the blue cap.
For the patient: To return the saliva sample in the tightly closed Salivette® Cortisol, follow the doctor's instructions and use the secondary container provided by the doctor and the shipping box/bag. If it is not
returned immediately, store this Salivette® Cortisol in the refrigerator.
For doctors and laboratories:
Because of the onset of bacterial growth in saliva after a few hours at room temperature, it is recommended to either centrifuge the firmly closed Salivette® Cortisol within 4 hours after specimen collection at
1,000 x g for 2 minutes and analyse it or to store it immediately in the refrigerator until further processing.
After centrifugation, take the insert including cap out of the conical bottom plastic tube.
The pure saliva for further analysis is found in the conical bottom of the plastic tube above the residues that are located in the reservoir of the conical bottom.
After analysis, dispose of the conical bottom plastic tube and the insert in a disposal container.

Disposal – for doctors and laboratories
1.

The general hygiene guidelines and regulations for the proper disposal of infectious material must be observed and complied with.

2.

Disposable gloves prevent the risk of infection.

3.

&RQWDPLQDWHGRUıOOHG6DOLYHWWH® Cortisol tubes must be disposed of in suitable containers for hazardous biological waste that can be subsequently autoclaved and incinerated.

4.

They must be disposed of in a suitable incinerator or by autoclaving (steam sterilisation).

6

EN
Literature
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / “Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol|”
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed., vol. 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Key for symbols and labels:

Article number

Batch number

Use byCE marking

In vitro diagnostic device

Follow the instructions for use

If reused: Risk of contamination

Store away from sunlight

Store in a dry place

Manufacturer

Country of manufacture

Technical modifications reserved.
All serious incidents relating to the product must be reported to the manufacturer and the competent national authority.

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BG

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ȭɇɁɀȾȼɅɎɁɉȼɍɊɆɄɎɁɉȼɇɁɆȼɌɛɋɌɄɋɌɁɀȼȾȼɉɁɉȼɍɇɚɉɓɁɉȼɎȼɋɌɊȽȼȾɃɀɌȼȾɊɃȼɎȾɊɌɁɉȼɎȼ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɄɄɃɋɊɇɃȾȼɅɎɁɋɌɁɀɊɍɎȼȾɁɉɄɎɁɊɎɇɁɆȼɌɛȾɎɊɌɄɓɁɉɍɖɀɄɆɏɎɄɛɎɊɌȽɄɓɆȼɃȼɎɌȼɉɍɋɊɌɎȞɍɇɏɓȼɅɓɁɉɁɁȾɖɃɈɊɂɉɊɉɁɃȼȽȼȾɉɊɋɌɁɀȼȾȼɉɁɉȼɋɌɊȽȼɎȼɍɖɑɌȼɉɛȾȼɅɎɁ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇȾɑɇȼɀɄɇɉɄɆ

ȪȿɌȼɉɄɓɁɉɄɛ
ȞɃɁɈȼɉɁɎɊɉȼɍɇɚɉɓɁɉȼɋɌɊȽȼɎɌɛȽȾȼɀȼɍɁɄɃȾɖɌɔɄɉȼɅɌȼɉɊɈɄɉɏɎɄɍɇɁɀɑɌȼɉɁɉɁ ɎɁɓɉɊɍɎɄɎȾɖɌɀɄɑɌȼɉɄ ɈɄɁɉɁɉȼɃɖȽɄɄɇɄɊɌȼɇɁɉɋɌɄɁɈɉȼɇɁɆȼɌɍɎȾȼɃȼɀȼɍɁɄɃȽɁȿɉɁɃȼɈɖɌɍɛȾȼɉɁɉȼɍɇɚɉɆȼɎȼ
ɍɖɍɍɎɌȼɉɄɓɉɄȾɁɕɁɍɎȾȼ
ȞɌɁɈɁɎɊɄɎɁɈɋɁɌȼɎɏɌȼɎȼɉȼɍɖɑɌȼɉɁɉɄɁɃȼȾɄɍɛɎɊɎɎɌȼɅɉɊɍɎɎȼɃȼɄɃɍɇɁɀȾȼɉɄɎɁɋȼɌȼɈɁɎɌɄȫɊɎȼɃɄɋɌɄɓɄɉȼɄɋɊɌȼɀɄȽȼɆɎɁɌɄȼɇɉɄɛɌȼɍɎɁɂȾɍɇɚɉɆȼɎȼɆɊɅɎɊɃȼɋɊɓȾȼɍɇɁɀɉɛɆɊɇɆɊɓȼɍȼɉȼɍɎȼɅɉȼ
ɎɁɈɋɁɌȼɎɏɌȼɍɁɋɌɁɋɊɌɖɓȾȼ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɀȼɍɁɒɁɉɎɌɊɐɏȿɄɌȼȾɌȼɈɆɄɎɁɉȼɓȼɍȼɋɇɖɎɉɊɃȼɎȾɊɌɁɉȼɄɀȼɍɁȼɉȼɇɄɃɄɌȼɄɇɄɉȼɋɌȼȾɊɀȼɍɁɍɖɑɌȼɉɄȾɑɇȼɀɄɇɉɄɆɀɊɋɊɉȼɎȼɎɖɔɉȼɎȼɊȽɌȼȽɊɎɆȼ

ȞɃɁɈȼɉɁɉȼɋɌɊȽɄɄɏɋɊɎɌɁȽȼ
ȫȬȪȳȡȮȡȮȡȮȪȣȤȠȪȦȯȨȡȩȮȤȣȲȻȧȪȫȬȡȠȤȠȜȣȜȫȪȳȩȡȮȡȭȞȣȡȨȜȩȡȮȪȩȜȭȧȺȩȳȡȩȜȫȬȪȝȜȬȼȽɊɎɉɄɈȼɎɁɌɄȼɇɄɉɁɊȽɑɊɀɄɈɄɃȼȾɃɁɈȼɉɁɎɊɉȼɋɌɊȽɄ
1.

ȬɖɆȼȾɄɒɄɋɌɁɍɎɄɇɆȼɊɓɄɇȼɄɇɄɀɌɏȿɊɋɊɀɑɊɀɛɕɊɃȼɕɄɎɉɊɊȽɇɁɆɇɊɃȼɃȼɕɄɎȼɊɎɋȼɎɊȿɁɉɄɋɌɁɉɊɍɄɈɄɍɖɍɍɇɚɉɆȼɎȼɄɇɄɀɌɏȿɄɋɊɎɁɉɒɄȼɇɉɊɄɉɐɁɆɒɄɊɃɉɄɈȼɎɁɌɄȼɇɄ

2.

ȝɌɊɅ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɍɖȿɇȼɍɉɊɏɆȼɃȼɉɄɛɎȼɉȼɇɁɆȼɌɛ

3.

ȫɊɋɖɇɉɁɎɁɄɉɐɊɌɈȼɒɄɛɎȼɃȼɄɀɁɉɎɄɐɄɆȼɒɄɛɉȼɋɌɊȽȼɎȼ ȾɖɌɑɏɁɎɄɆɁɎȼ 

8BGȞɃɁɈȼɉɁɉȼɋɌɊȽȼ
- 60 min

- 50

- 40

- 30

- 20

- 10 min0ɈɄɉɏɎɄȽɁɃɀȼ
ɀɖȾɓɁɎɁ
1-5 secHƴO

2 min1000 x gȫɌɊȽȼȪɍɎȼɎɖɒɄ

ȞɃɁɈȼɉɁɎɊɉȼɍɇɚɉɓɁɉȼɋɌɊȽȼɎɌɛȽȾȼɀȼɍɁɄɃȾɖɌɔɄɉȼɅɌȼɉɊɈɄɉɏɎɄɍɇɁɀɑɌȼɉɁɉɁ ɎɁɓɉɊɍɎɄɎȾɖɌɀɄɑɌȼɉɄ ɈɄɁɉɁɉȼɃɖȽɄɄɇɄɊɌȼɇɁɉɋɌɄɁɈɉȼɇɁɆȼɌɍɎȾȼɃȼɀȼɍɁɄɃȽɁȿɉɁɃȼɈɖɌɍɛȾȼɉɁɉȼ
ɍɇɚɉɆȼɎȼɍɖɍɍɎɌȼɉɄɓɉɄȾɁɕɁɍɎȾȼȤɃɋɇȼɆɉɁɎɁɏɍɎȼɎȼɍȾɊɀȼɃȼɊɆɊɇɊɍɁɆɏɉɀɄɈȼɆɍɄɈɏɈɈɄɉɏɎɄɋɌɁɀɄȾɃɁɈȼɉɁɎɊɉȼɋɌɊȽȼ
ȤɃɈɄɅɎɁɄɄɃɍɏɔɁɎɁɌɖɒɁɎɁɍɄɉɁɋɊɍɌɁɀɍɎȾɁɉɊɋɌɁɀɄȾɃɁɈȼɉɁɎɊɉȼɍɇɚɉɓɁɉȼɎȼɋɌɊȽȼ
ȱȾȼɉɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉɃȼɃȼɀɉɄɛɆɌȼɅɍɀȾȼɋɌɖɍɎȼɄɃȾȼɀɁɎɁȿɊɊɎɊɎȾɊɌɁɉȼɎȼ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɄ
ɄȿɊɋɊɍɎȼȾɁɎɁȾɏɍɎȼɎȼ
ȪɍɎȼȾɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉȾɏɍɎȼɎȼɃȼɈɄɉɏɎɄȽɁɃɀȼȿɊɀɖȾɓɁɎɁ ɉȼɋɌɄɈɁɌȾɆɏɑɄɉȼɎȼɉȼȽɏɃȼɎȼ ȨɄɉɄɈȼɇɉɊɎɊɆɊɇɄɓɁɍɎȾɊɋɊɁɎȼɍɇɚɉɆȼɎɌɛȽȾȼɀȼɁƐOȫɌɄɈɉɊȿɊɍɇȼȽɊɍɇɚɉɆɊɊɎɀɁɇɛɉɁ
ɊɍɎȼȾɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉɋɊɀɖɇȿɊȾɏɍɎȼɎȼ
ȱȾȼɉɁɎɁɋȼɈɏɓɉɄɛɎȼɈɋɊɉɃȼɃȼɀɉɄɛɆɌȼɅɍɀȾȼɋɌɖɍɎȼɄɃȾȼɀɁɎɁȿɊɊɎɏɍɎȼɎȼɄ
ɉɁɃȼȽȼȾɉɊȿɊɋɊɍɎȼȾɁɎɁȾ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇȭɇɁɀɎɊȾȼɃȼɎȾɊɌɁɎɁɍɖɍɍɄɉɛɎȼɃȼɋɏɔȼɇɆȼ
ȣȼɋȼɒɄɁɉɎȼȭɇɁɀȾȼɅɎɁɉȼɍɊɆɄɎɁɉȼɇɁɆȼɌɛɋɌɄɋɌɁɀȼȾȼɉɁɉȼɍɇɚɉɓɁɉȼɎȼɋɌɊȽȼȾɃɀɌȼȾɊɃȼɎȾɊɌɁɉȼɎȼ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɄɄɃɋɊɇɃȾȼɅɎɁɋɌɁɀɊɍɎȼȾɁɉɄɎɁɊɎɇɁɆȼɌɛȾɎɊɌɄɓɁɉɍɖɀɄɆɏɎɄɛɎɊɌȽɄɓɆȼ
ɃȼɎɌȼɉɍɋɊɌɎȞɍɇɏɓȼɅɓɁɉɁɁȾɖɃɈɊɂɉɊɉɁɃȼȽȼȾɉɊɋɌɁɀȼȾȼɉɁɉȼɋɌɊȽȼɎȼɍɖɑɌȼɉɛȾȼɅɎɁ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇȾɑɇȼɀɄɇɉɄɆ
ȣȼɇɁɆȼɌɛɄɇȼȽɊɌȼɎɊɌɄɛɎȼ
ȫɊɎȼɃɄɋɌɄɓɄɉȼɄɋɊɌȼɀɄȽȼɆɎɁɌɄȼɇɉɄɛɌȼɍɎɁɂȾɍɇɚɉɆȼɎȼɆɊɅɎɊɃȼɋɊɓȾȼɍɇɁɀɉɛɆɊɇɆɊɓȼɍȼɉȼɍɎȼɅɉȼɎɁɈɋɁɌȼɎɏɌȼɍɁɋɌɁɋɊɌɖɓȾȼɍɇɁɀȾɃɁɈȼɉɁɎɊɉȼɋɌɊȽȼɎȼ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɄɇɄɀȼɍɁ
ɒɁɉɎɌɊɐɏȿɄɌȼȾɌȼɈɆɄɎɁɉȼɓȼɍȼɋɌɄ[JɃȼɈɄɉɏɎɄɄɇɄɉɁɃȼȽȼȾɉɊɀȼɍɁɋɊɍɎȼȾɄɄɍɖɑɌȼɉɛȾȼȾɑɇȼɀɄɇɉɄɆɀɊɋɊɉȼɎȼɎɖɔɉȼɎȼɊȽɌȼȽɊɎɆȼ
ȭɇɁɀɒɁɉɎɌɊɐɏȿɄɌȼɉɁɎɊɄɃȾȼɀɁɎɁȾɄɍɛɕɄɛɍɖɀɃȼɁɀɉɊɍɖɍɃȼɋɏɔȼɇɆȼɎȼɊɎɋɇȼɍɎɈȼɍɊȾȼɎȼɁɋɌɏȾɁɎɆȼɍɊɍɎɌɊɀɖɉɊ
ȳɄɍɎȼɎȼɍɇɚɉɆȼɃȼɋɊɉȼɎȼɎɖɔɁɉȼɉȼɇɄɃɊɍɎȼȾȼɉȼɀɖɉɊɎɊɉȼɋɇȼɍɎɈȼɍɊȾȼɎȼɁɋɌɏȾɁɎɆȼɉȼɀɊɍɎȼɎɖɒɄɎɁɆɊɄɎɊɍɁɉȼɈɄɌȼɎȾɌɁɃɁɌȾɊȼɌȼɉȼɊɍɎɌɊɎɊɀɖɉɊ
ȭɇɁɀȼɉȼɇɄɃȼɄɃɑȾɖɌɇɁɎɁɋɇȼɍɎɈȼɍɊȾȼɎȼɁɋɌɏȾɁɎɆȼɍɊɍɎɌɊɀɖɉɊɄȾɄɍɛɕɄɛɍɖɀȾɋɊɀɑɊɀɛɕɆɊɉɎɁɅɉɁɌɃȼɊɎɋȼɀɖɒɄ

ȤɃɑȾɖɌɇɛɉɁşȾȼɂɄɃȼɇɁɆȼɌɛɄɇȼȽɊɌȼɎɊɌɄɛɎȼ
1.

ȭɋȼɃȾȼɅɎɁɊȽɕɄɎɁɑɄȿɄɁɉɉɄɉȼɍɊɆɄɄɃȼɆɊɉɊȾɄɉȼɌɁɀȽɄɃȼɋɌȼȾɄɇɉɊɎɊɄɃɑȾɖɌɇɛɉɁɉȼɄɉɐɁɆɒɄɊɃɉɄɈȼɎɁɌɄȼɇɄ

2.

ȬɖɆȼȾɄɒɄɎɁɃȼɁɀɉɊɆɌȼɎɉȼɏɋɊɎɌɁȽȼɋɌɁɀɊɎȾɌȼɎɛȾȼɎɌɄɍɆȼɊɎɄɉɐɁɆɒɄɄ

3.

ȣȼɈɖɌɍɁɉɄɎɁɄɇɄɋɖɇɉɄ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɎɌɛȽȾȼɀȼɍɁɄɃɑȾɖɌɇɛɎȾɋɊɀɑɊɀɛɕɄɆɊɉɎɁɅɉɁɌɄɃȼɊɋȼɍɉɄȽɄɊɇɊȿɄɓɉɄɊɎɋȼɀɖɒɄɍɇɁɀɆɊɁɎɊɈɊȿȼɎɀȼȽɖɀȼɎȼȾɎɊɆɇȼȾɄɌȼɉɄɄɄɃȿɊɌɁɉɄ

4.

ȪɎɋȼɀɖɓɉɄɎɁɋɌɊɀɏɆɎɄɎɌɛȽȾȼɀȼɈɄɉȼɎɋɌɁɃɋɊɀɑɊɀɛɕɄɉɍɄɉɁɌȼɎɊɌɄɇɄɋɌɊɒɁɍɉȼȼȾɎɊɆɇȼȾɄɌȼɉɁ ɍɎɁɌɄɇɄɃȼɒɄɛɍɋȼɌȼ 

9BGȧɄɎɁɌȼɎɏɌȼ
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

ȦɊɀɉȼɍɄɈȾɊɇɄɄɄɀɁɉɎɄɐɄɆȼɒɄɄ

ȩɊɈɁɌɉȼȼɌɎɄɆɏɇ

ȫȼɌɎɄɀȼ

ȟɊɀɁɉɀɊ

ȭȡɈȼɌɆɄɌɊȾɆȼ

ȤɉȾɄɎɌɊɀɄȼȿɉɊɍɎɄɆȼ

ȭɋȼɃȾȼɅɎɁɌɖɆɊȾɊɀɍɎȾɊɎɊɃȼɏɋɊɎɌɁȽȼ

ȫɌɄɋɊȾɎɊɌɉȼɏɋɊɎɌɁȽȼȪɋȼɍɉɊɍɎɊɎɆɊɉɎȼɈɄɉȼɒɄɛ

ȫȼɃɁɎɁɊɎɍɇɖɉɓɁȾȼɍȾɁɎɇɄɉȼ

ȭɖɑɌȼɉɛȾȼɅɎɁɉȼɍɏɑɊ

ȫɌɊɄɃȾɊɀɄɎɁɇ

ȠɖɌɂȼȾȼɉȼɋɌɊɄɃȾɊɀɍɎȾɊ

ȣȼɋȼɃȾȼɍɁɋɌȼȾɊɎɊɃȼɄɃȾɖɌɔȾȼɉɁɉȼɎɁɑɉɄɓɁɍɆɄɋɌɊɈɁɉɄ
ȞɍɄɓɆɄɍɁɌɄɊɃɉɄɄɉɒɄɀɁɉɎɄɍȾɖɌɃȼɉɄɍɋɌɊɀɏɆɎȼɎɌɛȽȾȼɀȼɍɁɍɖɊȽɕȼȾȼɎɉȼɋɌɊɄɃȾɊɀɄɎɁɇɛɄɉȼɆɊɈɋɁɎɁɉɎɉɄɛɉȼɒɄɊɉȼɇɁɉɊɌȿȼɉ

10

Návod k obsluze – SARSTEDT Salivette® CortisolCS³ÕHOSRXĭLWì
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12

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Literatura
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2).OìÕSURV\PERO\DbR]QDÕHQìqìVORYĨURENX

2]QDÕHQìđDUĭH

3RXĭLWHOQÜGR2]QDÕHQì&('LDJQRVWLFNĨ]GUDYRWQLFNĨSURVWčHGHN in vitro'RGUĭXMWHQÈYRGNbSRXĭLWì

3čLRSDNRYDQÜPSRXĭLWìQHEH]SHÕìNRQWDPLQDFH

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Brugsanvisning – SARSTEDT Salivette® CortisolDA3ÎWÑQNWDQYHQGHOVH
Salivette® Cortisol er et prøverør til spytprøver, derbruges til opsamling, transport, behandling og opbevaring af spyt til in vitro diagnostisk bestemmelse af cortisol. Produktet er beregnet til brug i et professionelt miljø og
til anvendelse af medicinsk fag- og laboratoriepersonale.

3URGXNWEHVNULYHOVH
Salivette® Cortisol består af et gennemsigtigt plastikrør med spids bund, et indlæg, en sugerulle og en blå prop.

51.1534.500=

Plastikbeholder+Indlæg+Sugerulle+Blå prop

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1.

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2.

Generelle forholdsregler: Brug handsker og andet generelt personligt beskyttelsesudstyr for at beskytte dig mod mulig eksponering for potentielt infektiøse prøver. Din institutions sikkerhedsretningslinjer og-procedurer skal følges.

3.

Det spyt, der er opsamlet og behandlet med Salivette® Cortisol, er ikke beregnet til tilbageførsel i den menneskelige organisme.

4.

Brug ikke Salivette® Cortisolefter holdbarhedsdatoen. Holdbarheden af Salivette® Cortisol slutter på sidste dag af den angivne måned og det angivne år.

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Salivette® Cortisol skal opbevares ved rumtemperatur før brug.

Transport
Produktet kan transporteres manuelt internt på faciliteten sammen med en sekundærbeholder, som er i overensstemmelse med ADR (pakningsinstruktion P650). Til prøvetransporten af Salivette® Cortisol anbefales en
forsendelsesbeholder med varenr. 78.898, som er i overensstemmelse med ADR (pakningsinstruktion P650), med sugeindlæg plus skruelukning med varenr. 65.679 samt en forsendelsesboks/-pose.
Til patient:
Ved returnering af spytprøven i det fastlukkede Salivette® Cortisolrør skal du følge lægens anvisninger, og bruge den sekundære beholder og forsendelsesboksen/-posen, som lægen har stillet til rådighed. Hvis
returneringen ikke sker direkte, skal Salivette® Cortisol opbevares i køleskab.

Begrænsninger
Spytprøveindsamlingen skal tidligst ske 60 minutter efter et måltid (optagelse af flydende/fast ernæring), tandbørstning eller oral indtagelse af lægemidler for at undgå kontamination af spyttet med forstyrrende
substanser.
Opbevaringstid og temperatur afhænger af holdbarheden af de parametre, der skal undersøges. Derfor og på grund af bakterievæksten i spyttet, der ved stuetemperatur allerede starter efter et par timer, anbefales, at
Salivette® Cortisol lukkes tæt umiddelbart efter prøvetagningen, og enten centrifugeres og analyseres inden for fire timer eller opbevares i køleskabet indtil videre bearbejdning.

3UĉYHWDJQLQJRJKÎQGWHULQJLÆS HELE DOKUMENTET OMHYGGELIGT IGENNEM, INDEN DU PÅBEGYNDER SPYTOPSAMLINGEN.
Materiale, der kræves til prøveudtagning:
1.

Handsker, kittel, øjenværn eller anden passende beskyttelsesbeklædning til beskyttelse mod spytbårne sygdomsfremkaldende organismer eller potentielt smitsomme materialer.

2.

Antal Salivette® Cortisol i henhold til lægens ordinering.

3.

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Prøvetagning– 60 min – 50

– 40

– 30

– 20

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0

2 min. uden
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2 min.
1000 x g

Prøve

ResterSpytprøveindsamlingen skal tidligst ske 60 minutter efter et måltid (optagelse af flydende/fast ernæring), tandbørstning eller oral indtagelse af lægemidler for at undgå kontamination af spyttet med forstyrrende
substanser. Skyl munden med vand i 1-5 sekunder i op til 10 minutter før prøvetagningen.
Vask, og tør hænderne umiddelbart før spytprøveindsamlingen.
Tag sugerullen med to fingre fra den bageste del ud af det åbnede Salivette® Cortisol rør, ogSODFÜUGHQLPXQGHQ
Sugerullen skal blive i munden (f.eks. i kinden) i 2 minutter uden at foretage tyggebevægelser. Den mindste mængde af spyt, der skal opsamles, er 500 μl. Lad sugerullen ligge længere i munden ved ekstrem lav
spytdannelse.
Tag sugerullen ud af munden ved med to fingre at tage fat i den bageste del, og
stik den direkte ind i Salivette® Cortisol røret, og luk det med den blå prop.
Til patient: Ved returnering af spytprøven i det fastlukkede Salivette® Cortisolrør skal du følge lægens anvisninger, og bruge den sekundære beholder og forsendelsesboksen/-posen, som lægen har stillet tilrådighed. Hvis returneringen ikke sker direkte, skal Salivette® Cortisol opbevares i køleskab.
Til læge og laboratorium:På grund af bakterievæksten i spyttet, der allerede starter efter et par timer, anbefales, at Salivette® Cortisol røret lukkes tæt umiddelbart efter prøvetagningen, og enten centrifugeres ved 1.000 x g i 2 minutter, og
analyseres inden for fire timer, eller opbevares i køleskab indtil videre bearbejdning.
Efter centrifugering tages indlægget inklusive propper ud af plastikrøret med den spidse bund.
I plastikrørets spidse bund er det rene spyt, der kan bruges til yderligere analyse vha de rester, der befinder sig i reservoiret i den spidse bund.
Efter analysen skal plastikrøret med den spidse bund og indlægget bortskaffes i en bortskaffelsesbeholder.

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1.

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Engangshandsker formindsker derved risikoen for infektion.

3.

Kontaminerede eller fyldte Salivette®&RUWLVROUĉUVNDOERUWVNDĳHVLHQHJQHWERUWVNDĳHOVHVEHKROGHUWLOELRORJLVNIDUOLJHVWRĳHUVRPHIWHUIĉOJHQGHNDQDXWRNODYHUHVRJEUÑQGHV4.

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15

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Litteratur
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

6\PERORJLGHQWLıFHULQJVNRGHU

Varenummer

Batchnummer

Mindst holdbar til

CE-mærke

In-vitro-diagnostik

Følg brugervejledningen

Ved genanvendelse: Fare for kontaminering

Opbevares beskyttet mod sollys

Opbevares tørt

ProducentFremstillingsland

Der tages forbehold for tekniske ændringer.
Alle alvorlige hændelser, der er opstået i forbindelse med dette produkt, skal meddeles producenten og den ansvarlige nationale myndighed.

16ǠǳǶǲǮǴǿȄǾǭȀǴȆǿş6$567('76DOLYHWWH® CortisolELǡǾǽǽǾǸǵȉƑǴǻǶȄǾǭȀǶ
Ǥǽ6DOLYHWWH®&RUWLVROǴǮǻǰǸǬǻǰȃǸǰǺǮǳǸǽǳǴǸǲƑǫȁȆǻǲǸǰǳǴǮǲƑǰȁǰȀǸǬǺǽȂǹǰǸȄǾǶȀǸƑǽƒǽǸǴǮȁǰǸǲǸǰȁǶǺǭȅǶȁǶƑǴȁǰȃǽǾǫȁǶǻǴƒǴǼǴǾǲǰȀǮǰǹǰǸȁǶǻǰƒǽǷǭǹǴȂȀǶȀǮǴǺǽȂǲǸǰȁǽǻin-vitroǳǸǰǲǻȆȀȁǸǹȉƒǾǽȀǳǸǽǾǸȀƑȉȁǶǿǹǽǾȁǸǵȉǺǶǿǤǽƒǾǽȇȉǻƒǾǽǽǾǮǵǴȁǰǸǲǸǰȁǶǻǴȃǰǾƑǽǲǭȀǴǴƒǰǲǲǴǺƑǰȁǸǹȉƒǴǾǸǱǫǺǺǽǻǹǰǸǲǸǰȄǾǭȀǶǰƒȉǹǰȁǰǾȁǸȀƑǬǻǽǸǰȁǾǸǹȉǹǰǸǴǾǲǰȀȁǶǾǸǰǹȉƒǾǽȀȆƒǸǹȉǡǴǾǸǲǾǰȃǭƒǾǽȇȉǻȁǽǿ
Ǥǽ6DOLYHWWH®&RUWLVROǰƒǽȁǴǺǴǮȁǰǸǰƒȉǬǻǰǳǸǰȃǰǻǬǿƒǺǰȀȁǸǹȉȃǸǰǺǮǳǸǽƑǴǹȆǻǸǹȉƒȂǷƑǬǻǰǬǻǰǴȀȆȁǴǾǸǹȉȃǸǰǺǮǳǸǽǴǻǰǸȆǾǭƑǰȁǽǿǬǻǰǻǰƒǽǾǾǽȃǶȁǸǹȉǹȊǺǸǻǳǾǽǹǰǸǬǻǰǲǰǺǫǵǸǽƒȋƑǰ51.1534.500=

ǡǺǰȀȁǸǹȉǳǽȄǴǮǽ

+ǴȀȆȁǴǾǸǹȉȃǸǰǺǮǳǸǽǴǻǰǸȆǾǭƑǰȁǽǿ

+ǰƒǽǾǾǽȃǶȁǸǹȉǿǹȊǺǸǻǳǾǽǿ+ǕǰǺǫǵǸǽƒȋƑǰǠǳǶǲǮǴǿǰȀȃǰǺǴǮǰǿǹǰǸƒǾǽǴǸǳǽƒǽǸǭȀǴǸǿ
1.

ǤǽƒǾǽȇȉǻǳǴǻƒǾǬƒǴǸǻǰȄǾǶȀǸƑǽƒǽǸǴǮȁǰǸȀǴƒǰǸǳǸǫǹǫȁȆȁȆǻǴȁȋǻǭȀǴǫȁǽƑǰƑǴǰȂǼǶƑǬǻǽǹǮǻǳȂǻǽǹǰȁǫƒǽȀǶǿ

2.

ǕǴǻǸǹǬǿƒǾǽȃȂǺǫǼǴǸǿǧǾǶȀǸƑǽƒǽǸǴǮȁǴǲǫǻȁǸǰǹǰǸǫǺǺǽǲǴǻǸǹȉǰȁǽƑǸǹȉƒǾǽȀȁǰȁǴȂȁǸǹȉǴǼǽƒǺǸȀƑȉǲǸǰȁǶǻƒǾǽȀȁǰȀǮǰȀǰǿǰƒȉȁǶǻƒǸǷǰǻǭǬǹǷǴȀǶȀǴǺǽǸƑȋǳǶȂǺǸǹǫǳǴǮǲƑǰȁǽǿǠǸǽǳǶǲǮǴǿǹǰǸǽǸǳǸǰǳǸǹǰȀǮǴǿǰȀȃǰǺǴǮǰǿȁǽȂǸǳǾȊƑǰȁȉǿȀǰǿƒǾǬƒǴǸǻǰȁǶǾǽȊǻȁǰǸ3.

ǠȀǮǴǺǽǿƒǽȂȀȂǺǺǬǲǴȁǰǸǹǰǸȂƒǽǱǫǺǺǴȁǰǸȀǴǴƒǴǼǴǾǲǰȀǮǰƑǴȁǽ6DOLYHWWH®&RUWLVROǳǴǻƒǾǽǽǾǮǵǴȁǰǸǲǸǰǴƒǰǻǬǲȄȂȀǶȀȁǽǰǻǷǾȋƒǸǻǽȀȋƑǰ4.

ǝǶǻȄǾǶȀǸƑǽƒǽǸǴǮȁǴȁǽ6DOLYHWWH®&RUWLVROƑǴȁǫȁǽƒǬǾǰǿȁǶǿǶƑǴǾǽƑǶǻǮǰǿǺǭǼǶǿǘǳǸǰȁǶǾǶȀǸƑȉȁǶȁǰǴǻȉǿ6DOLYHWWH®&RUWLVROǺǭǲǴǸȁǶǻȁǴǺǴȂȁǰǮǰǶƑǬǾǰȁǽȂǰǻǰǲǾǰȃȉƑǴǻǽȂƑǭǻǰǹǰǸǬȁǽȂǿǦȊǺǰǼǶ
Ǥǽ6DOLYHWWH®&RUWLVROƒǾǬƒǴǸǻǰȃȂǺǫȀȀǴȁǰǸȀǴǷǴǾƑǽǹǾǰȀǮǰǳȆƑǰȁǮǽȂƒǾǸǻǰƒȉȁǶȄǾǭȀǶǝǴȁǰȃǽǾǫ
ǤǽƒǾǽȇȉǻƑƒǽǾǴǮǻǰƑǴȁǰȃǴǾǷǴǮȄǴǸǾǽǹǮǻǶȁǰǴǻȁȉǿȁȆǻǴǲǹǰȁǰȀȁǫȀǴȆǻǭȀǴǬǻǰǳǴȂȁǴǾǴȊǽǻȃǸǰǺǮǳǸǽȀȂƑǱǰȁȉƑǴ$'5 ǽǳǶǲǮǰȀȂȀǹǴȂǰȀǮǰǿ3 ǕǸǰȁǶƑǴȁǰȃǽǾǫǳǴǸǲƑǫȁȆǻȁǽȂ6DOLYHWWH®&RUWLVROȀȂǻǮȀȁǰȁǰǸǶȄǾǭȀǶȁǽȂȀȂƑǱǰȁǽȊƑǴ$'5ǳǽȄǴǮǽȂǰƒǽȀȁǽǺǭǿ ǽǳǶǲǮǰȀȂȀǹǴȂǰȀǮǰǿ3 ƑǴǹȆǳƒǾƑǴǰƒǽǾǾǽȃǶȁǸǹȉȂǺǸǹȉǹǰǸǱǸǳȆȁȉƒȋƑǰƑǴǹȆǳƒǾǹǰǷȋǿǴƒǮȀǶǿǹǰǸǶȄǾǭȀǶǴǻȉǿǹǽȂȁǸǽȊȀǰǹǽȊǺǰǿǰƒǽȀȁǽǺǭǿǕǸǰȁǽǻǰȀǷǴǻǭǕǸǰǻǰǴƒǸȀȁǾǬȅǴȁǴȁǽǳǴǮǲƑǰȀǮǴǺǽȂȀȁǽǴǾƑǶȁǸǹǫǹǺǴǸȀȁȉ6DOLYHWWH®&RUWLVROǰǹǽǺǽȂǷǭȀȁǴȁǸǿǽǳǶǲǮǴǿȁǽȂǸǰȁǾǽȊǹǰǸȄǾǶȀǸƑǽƒǽǸǭȀȁǴȁǽǳǴȂȁǴǾǴȊǽǻǳǽȄǴǮǽƒǽȂƒǰǾǬȄǴȁǰǸǰƒȉȁǽǻǸǰȁǾȉǹǰǸȁǽǹǽȂȁǮȀǫǹǽǰƒǽȀȁǽǺǭǿǖǫǻǳǴǻǴƒǸȀȁǾǰȃǴǮǰƒǴȂǷǴǮǰǿǰƒǽǷǶǹǴȊȀȁǴǰȂȁȉȁǽ6DOLYHWWH®&RUWLVROȀȁǽȅȂǲǴǮǽǡǴǾǸǽǾǸȀƑǽǮ
ǘǺǭȅǶȁǽȂȀǮǴǺǽȂƒǾǬƒǴǸǻǰǴǹȁǴǺǴǮȁǰǸȁǽǻȆǾǮȁǴǾǽǺǴƒȁǫƑǴȁǫǰƒȉǬǻǰǲǴȊƑǰ ǺǭȅǶȂǲǾǭǿȀȁǴǾǴǫǿȁǾǽȃǭǿ ǱǽȊǾȁȀǸȀƑǰȁȆǻǳǽǻȁǸȋǻǭǺǭȅǶȃǰǾƑǰǹǴȂȁǸǹǭǿǰǲȆǲǭǿǰƒȉȁǽȂȀȁȉƑǰȁǽǿƒǾǽǹǴǸƑǬǻǽȂǻǰǰƒǽȃǴȊǲǴȁǰǸǶƑȉǺȂǻȀǶȁǽȂȀǮǴǺǽȂǰƒȉǽȂȀǮǴǿƑǴǳǸǰȀƒǰȀȁǸǹǭǴƒǮǳǾǰȀǶǘǳǸǫǾǹǴǸǰȃȊǺǰǼǶǿǹǰǸǶǷǴǾƑǽǹǾǰȀǮǰǴǼǰǾȁȋǻȁǰǸǰƒȉȁǶǳǸǫǾǹǴǸǰǵȆǭǿȁȆǻƒǰǾǰƑǬȁǾȆǻƒǽȂƒǾǬƒǴǸǻǰǴǼǴȁǰȀȁǽȊǻǕǸǰȁǽǻǺȉǲǽǰȂȁȉǹǰǸǺȉǲȆȁǶǿǱǰǹȁǶǾǸǰǹǭǿǰǻǫƒȁȂǼǶǿȀȁǽǻȀǮǴǺǽƒǽȂǼǴǹǸǻǫƑǴȁǫǰƒȉƑǴǾǸǹǬǿȋǾǴǿȀǴǷǴǾƑǽǹǾǰȀǮǰǳȆƑǰȁǮǽȂȀȂǻǸȀȁǫȁǰǸǶȃȂǲǽǹǬǻȁǾǶȀǶǹǰǸǶǰǻǫǺȂȀǶȁǽȂ6DOLYHWWH®&RUWLVROǴǾƑǶȁǸǹǫǹǺǴǸȀƑǬǻǽȂǴǮȁǴǴǻȁȉǿȆǾȋǻƑǴȁǫȁǶǳǴǸǲƑǰȁǽǺǶȅǮǰǴǮȁǴǶǰƒǴȂǷǴǮǰǿȃȊǺǰǼǭȁǽȂȀȁǽȅȂǲǴǮǽǬȆǿȁǶǻƒǴǾǰǸȁǬǾȆǴƒǴǼǴǾǲǰȀǮǰǣȂǺǺǽǲǭǳǴǸǲƑǫȁȆǻǹǰǸȄǴǸǾǸȀƑȉǿƍǚǓǔǓǣǤǖǡǜǘǢƏǣǤǠǡǓǢǠǞǖǕǕǢǓǦǠǡǢǠǤǠǥǟǖǛǚǞǘǣǖǤǖǤǘǜǘǨǘǣǚǖǜǠǥǓƒǰǸȁǽȊƑǴǻǽǿǱǽǶǷǶȁǸǹȉǿǴǼǽƒǺǸȀƑȉǿǲǸǰȁǶȀȂǺǺǽǲǭǳǴǸǲƑǫȁȆǻ1.

ǕǫǻȁǸǰǾȉƑƒǰƒǾǽȀȁǰȁǴȂȁǸǹǫǲȂǰǺǸǫǭǫǺǺǶǹǰȁǫǺǺǶǺǶƒǾǽȀȁǰȁǴȂȁǸǹǭǴǻǳȂƑǰȀǮǰǲǸǰȁǶǻƒǾǽȀȁǰȀǮǰȀǰǿǰƒȉƒǰǷǽǲȉǻǽȂǿƑǸǹǾǽǽǾǲǰǻǸȀƑǽȊǿƒǽȂƑǴȁǰǳǮǳǽǻȁǰǸƑǬȀȆȁǽȂȀǮǴǺǽȂǭȁȂȄȉǻƑǽǺȂȀƑǰȁǸǹȋǻȂǺǸǹȋǻ

2.

ǡǽȀȉȁǶȁǰ6DOLYHWWH®&RUWLVROȀȊƑȃȆǻǰƑǴȁǽǰǮȁǶƑǰȁǽȂǸǰȁǾǽȊ

3.

ǣȂƑƒǺǶǾȋȀȁǴȁǰȀȁǽǸȄǴǮǰǲǸǰȁǶǻȁǰȂȁǽƒǽǮǶȀǶǳǴǸǲƑǫȁȆǻ ȀȁǶǻǴȁǸǹǬȁǰ 

17

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HƴOǺǴƒȁǫ
1.000 x gƍǴǮǲƑǰ

ǥƒǽǺǴǮƑƑǰȁǰ

ǘǺǭȅǶȁǽȂȀǮǴǺǽȂƒǾǬƒǴǸǻǰǴǹȁǴǺǴǮȁǰǸȁǽǻȆǾǮȁǴǾǽǺǴƒȁǫƑǴȁǫǰƒȉǬǻǰǲǴȊƑǰ ǺǭȅǶȂǲǾǭǿȀȁǴǾǴǫǿȁǾǽȃǭǿ ǱǽȊǾȁȀǸȀƑǰȁȆǻǳǽǻȁǸȋǻǭǺǭȅǶȃǰǾƑǰǹǴȂȁǸǹǭǿǰǲȆǲǭǿǰƒȉȁǽȂȀȁȉƑǰȁǽǿƒǾǽǹǴǸƑǬǻǽȂǻǰǰƒǽȃǴȊǲǴȁǰǸǶƑȉǺȂǻȀǶȁǽȂȀǮǴǺǽȂǰƒȉǽȂȀǮǴǿƑǴǳǸǰȀƒǰȀȁǸǹǭǴƒǮǳǾǰȀǶǟǴƒǺȊǻǴȁǴȁǽȀȁȉƑǰƑǴǻǴǾȉǲǸǰǳǴȂȁǴǾȉǺǴƒȁǰǬȆǿǹǰǸǺǴƒȁǫƒǾǸǻǰƒȉȁǶǳǴǸǲƑǰȁǽǺǶȅǮǰǡǺȊǻǴȁǴǹǰǸȀǹǽȂƒǮȀȁǴȁǰȄǬǾǸǰȀǰǿƒǾǸǻǰƒȉȁǶǺǭȅǶȁǽȂȀǮǴǺǽȂǓȃǰǸǾǬȀȁǴȁǽǻǰƒǽǾǾǽȃǶȁǸǹȉǹȊǺǸǻǳǾǽǰƒȉȁǽƒǮȀȆǫǹǾǽƑǴǳȊǽǳǫǹȁȂǺǰǰƒȉȁǽǰǻǽǸǹȁȉ6DOLYHWWH®&RUWLVROǹǰǸȁǽƒǽǷǴȁǭȀȁǴȁǽȀȁǽȀȁȉƑǰǠǰƒǽǾǾǽȃǶȁǸǹȉǿǹȊǺǸǻǳǾǽǿƒǾǬƒǴǸǻǰƒǰǾǰƑǴǮǻǴǸǲǸǰǺǴƒȁǫȀȁǽȀȁȉƑǰ ƒȄȀȁǶǻƒǰǾǴǸǰǹǭǹǽǸǺȉȁǶȁǰ ȄȆǾǮǿǹǸǻǭȀǴǸǿƑǫȀǶȀǶǿǘǴǺǫȄǸȀȁǶƒǽȀȉȁǶȁǰȀǮǴǺǽȂƒǽȂƒǾǬƒǴǸǻǰǺǰƑǱǫǻǴȁǰǸƒǾǬƒǴǸǻǰǴǮǻǰǸƑOǖǫǻǽȀȄǶƑǰȁǸȀƑȉǿȀǮǴǺǽȂǴǮǻǰǸǴǼǰǸǾǴȁǸǹǫȄǰƑǶǺȉǿǰȃǭȀȁǴȁǽǻǰƒǽǾǾǽȃǶȁǸǹȉǹȊǺǸǻǳǾǽǲǸǰƑǴǲǰǺȊȁǴǾǽǳǸǫȀȁǶƑǰƑǬȀǰȀȁǽȀȁȉƑǰǤǾǰǱǭǼȁǴȁǽǻǰƒǽǾǾǽȃǶȁǸǹȉǹȊǺǸǻǳǾǽǰƒȉȁǽƒǮȀȆǫǹǾǽƑǴǳȊǽǳǫǹȁȂǺǰǰƒȉȁǽȀȁȉƑǰǹǰǸȁǽƒǽǷǴȁǭȀȁǴȁǽǻǰƑǬȀȆǿƑǬȀǰȀȁǽ6DOLYHWWH®&RUWLVROǹǰǸȀȃǾǰǲǮȀȁǴȁǽƑǴȁǽƑƒǺǴƒȋƑǰǕǸǰȁǽǻǰȀǷǴǻǭǕǸǰǻǰǴƒǸȀȁǾǬȅǴȁǴȁǽǳǴǮǲƑǰȀǮǴǺǽȂȀȁǽǴǾƑǶȁǸǹǫǹǺǴǸȀȁȉ6DOLYHWWH®&RUWLVROǰǹǽǺǽȂǷǭȀȁǴȁǸǿǽǳǶǲǮǴǿȁǽȂǸǰȁǾǽȊǹǰǸȄǾǶȀǸƑǽƒǽǸǭȀȁǴȁǽǳǴȂȁǴǾǴȊǽǻǳǽȄǴǮǽƒǽȂƒǰǾǬȄǴȁǰǸǰƒȉȁǽǻǸǰȁǾȉǹǰǸȁǽǹǽȂȁǮȀǫǹǽǰƒǽȀȁǽǺǭǿǖǫǻǳǴǻǴƒǸȀȁǾǰȃǴǮǰƒǴȂǷǴǮǰǿǰƒǽǷǶǹǴȊȀȁǴǰȂȁȉȁǽ6DOLYHWWH®&RUWLVROȀȁǽȅȂǲǴǮǽǕǸǰȁǽǻǸǰȁǾȉǹǰǸȁǽǴǾǲǰȀȁǭǾǸǽǜȉǲȆȁǶǿǱǰǹȁǶǾǸǰǹǭǿǰǻǫƒȁȂǼǶǿȀȁǽǻȀǮǴǺǽƒǽȂǼǴǹǸǻǫƑǴȁǫǰƒȉƑǴǾǸǹǬǿȋǾǴǿȀǴǷǴǾƑǽǹǾǰȀǮǰǳȆƑǰȁǮǽȂȀȂǻǸȀȁǫȁǰǸǶȃȂǲǽǹǬǻȁǾǶȀǶǹǰǸǶǰǻǫǺȂȀǶȁǽȂ6DOLYHWWH®&RUWLVROǴǾƑǶȁǸǹǫǹǺǴǸȀƑǬǻǽȂǴǮȁǴǴǻȁȉǿȆǾȋǻȀǴ[JǲǸǰǺǴƒȁǫƑǴȁǫȁǶǳǴǸǲƑǰȁǽǺǶȅǮǰǴǮȁǴǶǰƒǴȂǷǴǮǰǿȃȊǺǰǼǭȁǽȂȀȁǽȅȂǲǴǮǽǬȆǿȁǶǻƒǴǾǰǸȁǬǾȆǴƒǴǼǴǾǲǰȀǮǰǝǴȁǫȁǶȃȂǲǽǹǬǻȁǾǶȀǶǰȃǰǸǾǬȀȁǴȁǽȃǸǰǺǮǳǸǽǴǻǰǸȆǾǭƑǰȁǽǿƑǰǵǮƑǴȁǽƒȋƑǰǰƒȉȁǽƒǺǰȀȁǸǹȉȃǸǰǺǮǳǸǽƑǴȁǽǻǹȆǻǸǹȉƒȂǷƑǬǻǰǣȁǽǻǹȆǻǸǹȉƒȂǷƑǬǻǰȁǽȂƒǺǰȀȁǸǹǽȊȃǸǰǺǸǳǮǽȂǱǾǮȀǹǴȁǰǸǽǹǰǷǰǾȉǿȀǮǴǺǽǿǲǸǰƒǴǾǰǸȁǬǾȆǰǻǫǺȂȀǶȁȆǻȂƒǽǺǴǸƑƑǫȁȆǻƒǽȂǱǾǮȀǹǽǻȁǰǸȀȁǽǴǻǰǸȋǾǶƑǰȁǽȂǹȆǻǸǹǽȊƒȂǷƑǬǻǰǝǴȁǫȁǶǻǰǻǫǺȂȀǶǰƒǽǾǾǮȅȁǴȁǽƒǺǰȀȁǸǹȉȃǸǰǺǮǳǸǽƑǴȁǽǻȀȁǾǽǲǲȂǺȉƒȂǷƑǬǻǰǹǰǸȁǽȃǸǰǺǮǳǸǽǴǻǰǸȆǾǭƑǰȁǽǿȀǴǬǻǰǳǽȄǴǮǽǰƒȉǾǾǸȅǶǿǓƒȉǾǾǸȅǶşǸȀȄȊǴǸǲǸǰȁǽǻǸǰȁǾȉǹǰǸȁǽǴǾǲǰȀȁǭǾǸǽ
1.

ǡǾǬƒǴǸǻǰǺǰƑǱǫǻǽǻȁǰǸȂƒȉȅǶǹǰǸǻǰȁǶǾǽȊǻȁǰǸǽǸǲǴǻǸǹǬǿǽǳǶǲǮǴǿȂǲǸǴǸǻǭǿǹǰǷȋǿǹǰǸǽǸǻǽƑǸǹǬǿǳǸǰȁǫǼǴǸǿǲǸǰȁǶǻǽǾǷǭǰƒȉǾǾǸȅǶƑǽǺȂȀƑǰȁǸǹȋǻȂǺǸǹȋǻ2.

ǤǰǲǫǻȁǸǰƑǮǰǿȄǾǭȀǶǿǰƒǽȁǾǬƒǽȂǻȀȁǶǻƒǴǾǮƒȁȆȀǶǰȂȁǭȁǽǻǹǮǻǳȂǻǽƑȉǺȂǻȀǶǿ3.

ǤǽƑǽǺȂȀƑǬǻǽǭǲǴƑǫȁǽ6DOLYHWWH®&RUWLVROƒǾǬƒǴǸǻǰǰƒǽǾǾǮƒȁǴȁǰǸȀǴǹǰȁǫǺǺǶǺǽǳǽȄǴǮǽǳǸǫǷǴȀǶǿǴƒǸǹǮǻǳȂǻȆǻǱǸǽǺǽǲǸǹȋǻȂǺǸǹȋǻȁǽǽƒǽǮǽƑƒǽǾǴǮȀȁǶȀȂǻǬȄǴǸǰǻǰȂƒǽǱǺǶǷǴǮȀǴǴƒǴǼǴǾǲǰȀǮǰȀǴǰȂȁȉǹǰȂȀȁǽǭǻǰǰƒǽȁǴȃǾȆǷǴǮ4.

ǘǰƒȉǾǾǸȅǶƒǾǬƒǴǸǻǰƒǾǰǲƑǰȁǽƒǽǸǴǮȁǰǸȀǴǹǰȁǫǺǺǶǺǶƑǽǻǫǳǰǰƒǽȁǬȃǾȆȀǶǿǭƑǬȀȆǴƒǴǼǴǾǲǰȀǮǰǿȀǴǰȂȁȉǹǰȂȀȁǽ ǰƒǽȀȁǴǮǾȆȀǶƑǴǰȁƑȉ 18

ELǔǸǱǺǸǽǲǾǰȃǮǰ
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

ǥƒȉƑǻǶƑǰȀȂƑǱȉǺȆǻǹǰǸǴƒǸȀǶƑǫǻȀǴȆǻǓǾǸǷƑȉǿƒǾǽȇȉǻȁǽǿ

ǓǾǸǷƑȉǿƒǰǾȁǮǳǰǿ

ǧǾǭȀǶǬȆǿǣȊƑǱǽǺǽ&(In-vitroǳǸǰǲǻȆȀȁǸǹȉǸǰȁǾǽȁǴȄǻǽǺǽǲǸǹȉƒǾǽȇȉǻǤǶǾǴǮȁǴȁǸǿǽǳǶǲǮǴǿȄǾǭȀǴȆǿ

ǣǴƒǴǾǮƒȁȆȀǶǴƒǰǻǰȄǾǶȀǸƑǽƒǽǮǶȀǶǿǛǮǻǳȂǻǽǿƑǽǺȊǻȀǴȆǻ

ǦȊǺǰǼǶȀǴȀǶƑǴǮǽƒǽȂǱǾǮȀǹǴȁǰǸƑǰǹǾǸǫǰƒȉȁǶǻǶǺǸǰǹǭǰǹȁǸǻǽǱǽǺǮǰ

ǦȊǺǰǼǶȀǴǼǶǾȉƑǬǾǽǿ

ǛǰȁǰȀǹǴȂǰȀȁǭǿ

ǧȋǾǰǹǰȁǰȀǹǴȂǭǿ

ǥƒȉȁǶǻǴƒǸȃȊǺǰǼǶȁǴȄǻǸǹȋǻȁǾǽƒǽƒǽǸǭȀǴȆǻǏǺǰȁǰȀǽǱǰǾǫƒǴǾǸȀȁǰȁǸǹǫƒǽȂǰȃǽǾǽȊǻȁǽƒǾǽȇȉǻǹǽǸǻǽƒǽǸǽȊǻȁǰǸȀȁǽǻǹǰȁǰȀǹǴȂǰȀȁǭǹǰǸȀȁǶǻǰǾƑȉǳǸǰǴǷǻǸǹǭǰǾȄǭ

19

Instrucciones de uso – SARSTEDT Salivette® cortisol

ES

8VRSUHYLVWRLa Salivette® cortisol es un recipiente para muestras de saliva que se utiliza para la extracción, el transporte, el procesamiento y el almacenamiento de saliva para diagnósticos analíticos LQbYLWUR de cortisol. El producto
está destinado para la aplicación en el ámbito profesional y el uso por parte de personal sanitario y personal de laboratorio.

Descripción del producto
La Salivette® cortisol consta de un recipiente de plástico transparente de fondo puntiagudo, un recipiente de suspensión, un rollo absorbente y un tapón azul.

51.1534.500=

Recipiente deplástico+

Recipiente desuspensión+

Rollo absorbente+

Tapón azul

,QGLFDFLRQHVGHVHJXULGDG\DGYHUWHQFLDV
1.

(OSURGXFWRQRGHEHXWLOL]DUVHHQQLþRVPHQRUHVGHbDþRVQLHQSDFLHQWHVFRQPD\RUULHVJRGHDWUDJDQWDPLHQWR

2.

Medidas generales de precaución: Utilice guantes y un equipo de protección personal general para protegerse de una posible exposición a material de muestra potencialmente infeccioso. Observe las directrices y
SURFHGLPLHQWRVGHVHJXULGDGGHVXFHQWURPÜGLFR3.

La saliva recogida y procesada con la Salivette® cortisol no es apta para su reintroducción en el cuerpo humano.

4.

No utilice la Salivette®FRUWLVROXQDYH]VXSHUDGDVXIHFKDGHFDGXFLGDG/DYLGDěWLOGHOD6DOLYHWWH®FRUWLVROWHUPLQDHOěOWLPRGìDGHOPHV\DþRLQGLFDGRV

Almacenamiento
La Salivette® cortisol debe almacenarse a temperatura ambiente antes de su uso.

Transporte
El producto se puede transportar de forma manual dentro del centro o con un contenedor secundario que cumpla con el ADR (instrucción de embalaje P650). Para transportar muestras con la Salivette® cortisol, se
recomienda utilizar el contenedor de envío conforme a la normativa ADR (instrucción de embalaje P650), n.º de art. 78.898, con plantilla absorbente y tapón de rosca, n.º de art. 65.679, así como una caja o bolsa detransporte.
Para el paciente:
Para entregar la muestra de saliva en la Salivette®FRUWLVROELHQFHUUDGRVLJDODVLQVWUXFFLRQHVGHOPÜGLFR\XWLOLFHHOUHFLSLHQWHVHFXQGDULR\ODFDMDREROVDGHHQYìRSURSRUFLRQDGRVSRUHOPÜGLFR6LODPXHVWUDQRVH
entrega en el momento, conserve la Salivette® cortisol en el frigorífico.

Limitaciones/DVDOLYDGHEHUHFRJHUVHDOPHQRVbPLQXWRVGHVSXÜVGHXQDFRPLGD LQJHVWDGHDOLPHQWRVOìTXLGRVRVĂOLGRV GHFHSLOODUVHORVGLHQWHVRGHLQJHULUPHGLFDPHQWRVSRUYìDRUDOSDUDHYLWDUODFRQWDPLQDFLĂQGHODVDOLYD
por sustancias que puedan interferir.
(OWLHPSR\ODWHPSHUDWXUDGHFRQVHUYDFLĂQGHSHQGHQGHODHVWDELOLGDGGHORVSDUÈPHWURVTXHVHYDQDDQDOL]DU3RUORWDQWR\GHELGRDTXHODSUROLIHUDFLĂQEDFWHULDQDHQODVDOLYDFRPLHQ]DGHVSXÜVGHXQDVKRUDV
a temperatura ambiente, se recomienda centrifugar y analizar la Salivette®FRUWLVROGHELGDPHQWHFHUUDGDGHQWURGHODVbKRUDVVLJXLHQWHVDODUHFRJLGDGHODPXHVWUDRJXDUGDUODGLUHFWDPHQWHHQHOIULJRUìILFRKDVWDVX
posterior procesamiento.

Extracción de la muestra y manipulación
LEA COMPLETAMENTE ESTE DOCUMENTO ANTES DE INICIAR LA RECOGIDA DE SALIVA.
Material de trabajo necesario para la extracción de la muestra:
1.

Guantes, bata, protección ocular u otra prenda de protección adecuada para protegerse de los patógenos transmitidos por la saliva o de materiales potencialmente infecciosos.

2.

Cantidad de Salivettes®FRUWLVROVHJěQODVLQGLFDFLRQHVGHOPÜGLFR3.

&XPSOLPHQWHODLQIRUPDFLĂQGHLGHQWLıFDFLĂQGHODPXHVWUD HQODHWLTXHWD 

20

ESExtracción de la muestra- 60 min

- 50

- 40

- 30

- 20

- 10 min0bPLQVLQPRYLPLHQWR
masticatorio
1-5 s

HƴO

2 min
1.000 x g

MuestraResiduos/DVDOLYDGHEHUHFRJHUVHDOPHQRVbPLQXWRVGHVSXÜVGHXQDFRPLGD LQJHVWDGHDOLPHQWRVOìTXLGRVRVĂOLGRV GHFHSLOODUVHORVGLHQWHVRGHLQJHULUPHGLFDPHQWRVSRUYìDRUDOSDUDHYLWDUODFRQWDPLQDFLĂQGHOD
VDOLYDSRUVXVWDQFLDVTXHSXHGDQLQWHUIHULU(QMXÈJXHVHODERFDFRQDJXDGXUDQWHDbVHJXQGRVKDVWDbPLQXWRVDQWHVGHWRPDUODPXHVWUD/ÈYHVH\VÜTXHVHODVPDQRVLQPHGLDWDPHQWHDQWHVGHODUHFRJLGDGHVDOLYD
Extraiga el rollo absorbente con dos dedos por el extremo posterior de la Salivette® cortisol abierto ycolóqueselo en la boca.
(OUROORDEVRUEHQWHGHEHSHUPDQHFHUHQODERFD SRUHMHPSORHQHOYHVWìEXOREXFDO GXUDQWHbPLQXWRVVLQPRYLPLHQWRPDVWLFDWRULR/DFDQWLGDGPìQLPDGHVDOLYDTXHGHEHUHFRJHUVHHVGHbƐO6LOD
producción de saliva es muy baja, deje el rollo absorbente en la boca durante más tiempo.
Saque el rollo absorbente de la boca con dos dedos por el extremo posterior,LQVÜUWHORLQPHGLDWDPHQWHHQOD6DOLYHWWH®FRUWLVRO\FLÜUUHORFRQHOWDSĂQD]XOPara el paciente: Para entregar la muestra de saliva en la Salivette®FRUWLVROGHELGDPHQWHFHUUDGDVLJDODVLQVWUXFFLRQHVGHOPÜGLFR\XWLOLFHHOUHFLSLHQWHVHFXQGDULR\ODFDMDREROVDGHHQYìRSURSRUFLRQDGRVSRU
HOPÜGLFR6LODPXHVWUDQRVHHQWUHJDHQHOPRPHQWRFRQVHUYHOD6DOLYHWWH® cortisol en el frigorífico.
3DUDHOPÜGLFR\HOODERUDWRULR
'HELGRDTXHODSUROLIHUDFLĂQEDFWHULDQDHQODVDOLYDFRPLHQ]DGHVSXÜVGHXQDVKRUDVDWHPSHUDWXUDDPELHQWHVHUHFRPLHQGDFHQWULIXJDU\DQDOL]DUHO6DOLYHWWH® cortisol debidamente cerrada dentro de las
bKRUDVVLJXLHQWHVDODUHFRJLGDGHODPXHVWUDD[JGXUDQWHbPLQXWRVRJXDUGDUODGLUHFWDPHQWHHQHOIULJRUìILFRKDVWDVXSRVWHULRUSURFHVDPLHQWR'HVSXÜVGHODFHQWULIXJDFLĂQUHWLUHHOUHFLSLHQWHGHVXVSHQVLĂQLQFOXLGRHOWDSĂQGHOUHFLSLHQWHGHSOÈVWLFRGHIRQGRSXQWLDJXGREn el fondo puntiagudo del recipiente de plástico se encuentra la saliva pura para el posterior análisis de los residuos que se encuentran en el depósito del fondo.
'HVSXÜVGHODQÈOLVLVGHVHFKHHOUHFLSLHQWHGHSOÈVWLFRGHIRQGRSXQWLDJXGR\HOUHFLSLHQWHGHVXVSHQVLĂQHQXQFRQWHQHGRUGHHOLPLQDFLĂQ(OLPLQDFLĂQVHDSOLFDDOPÜGLFR\DOODERUDWRULR
1.

Se deben observar y cumplir las directivas sobre higiene general y las disposiciones legales para la eliminación correcta de material infeccioso.

2.

El uso de guantes desechables evita el riesgo de infección.

3.

Las Salivettes® cortisol usadas o contaminados deben desecharse en contenedores de eliminación adecuados para la eliminación de materiales biológicos peligrosos que admitan un posterior procesamiento en
autoclave e incineración.

4.

/DHOLPLQDFLĂQGHEHOOHYDUVHDFDERHQXQDSODQWDLQFLQHUDGRUDDGHFXDGDRDWUDYÜVGHXQSURFHVRGHDXWRFODYH HVWHULOL]DFLĂQSRUYDSRU 

21

ES
Literatura
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literatura / «Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol»
Kirschbaum, Hellhammer «Salivary Cortisol», Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Leyendas de símbolos y marcas:

1ěPHURGHDUWìFXOR

Código de loteFecha de caducidad

Marcado CE

DiagnósticoLQbYLWUR&RQVěOWHQVHODVLQVWUXFFLRQHVGHXVR

En caso de reutilización: peligro de contaminación0DQWÜQJDVHDOHMDGRGHODOX]VRODU

0DQWÜQJDVHVHFR

FabricantePaís de fabricación

5HVHUYDGRHOGHUHFKRDUHDOL]DUPRGLILFDFLRQHVWÜFQLFDVCualquier incidente grave relacionado con el producto debe ser notificado al fabricante y a la autoridad nacional competente.

22

Kasutusjuhend – SARSTEDT Salivette®CortisolET.DVXWXVRWVWDUYHSalivette® Cortisol on süljeproovinõu, mis on mõeldud sülje võtmiseks, transportimiseks, töötlemiseks ja ladustamiseks kortisooli in vitro diagnostikas. Toode on ette nähtud professionaalses keskkonnas ning erialasele
meditsiini- ja laboripersonalile kasutamiseks.

7RRWHNLUMHOGXVSalivette® Cortisol koosneb läbipaistvast terava põhjaga plastnõust, sissepandavast nõust, vatirullist ja sinisest korgist.

51.1534.500=

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Sissepandav nõu+

Vatirull+Sinine kork

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1.

7RRGHWHLWRKLNDVXWDGDDOODDDVWDYDQXVWHODVWHMDVXXUHQHQXGDOODQHHODPLVRKXJDSDWVLHQWLGHSXKXO

2.

Üldised ettevaatusabinõud Kasutage kindaid ja teisi üldisi isikukaitsevahendeid, et kaitsta ennast võimaliku kokkupuute eest potentsiaalselt nakkusliku proovimaterjaliga. Järgima peab meditsiiniasutuse
ohutussuuniseid ja -protseduure.

3.

Süsteemiga Salivette® Cortisol saadud ja töödeldud sülg ei ole ette nähtud tagasiviimiseks inimese kehasse.

4.

Ärge kasutage süsteemi Salivette® Cortisol pärast säilivuskuupäeva möödumist. Süsteemi Salivette® Cortisol säilivusaeg lõpeb äratoodud kuu ja aasta viimasel päeval.

Ladustamine
Süsteemi Salivette® Cortisol tuleb enne kasutamist ladustada toatemperatuuril.

Transport
Toodet saab ettevõtte sisesi transportida käsitsi või koos sekundaarse mahutiga, mis on kooskõlas ADRi eeskirjaga (pakendamisjuhisega P650). Süsteemi Salivette® Cortisol proovide transportimiseks soovitatakse ADRi
eeskirjaga (pakendamisjuhisega P650) kooskõlas olevat saatmisnõud, artikli nr 78.898, koos imava siseosa ja keermessulguriga, artikli nr 65.679, ning saatmiskarpi/-kotti.
Patsiendile:
Süljeproovi tagastamiseks tihedalt suletud süsteemis Salivette® Cortisol järgige arsti juhiseid ning kasutage arsti antud sekundaarset anumat ja saatmiskarpi/-kotti. Juhul kui ei tagastata kohe, siis hoidke süsteemi
Salivette® Cortisol külmikus.

Piirangud
Süljeproov tuleb võtta kõige varem 60 minutit pärast söömist (vedela/tahke toidu tarbimist), hammaste pesemist või ravimite suukaudset võtmist, et vältida sülje saastumist teiste ainetega.
Ladustamiskestus ja -temperatuur olenevad uuritavate parameerite säilivusest. Toatemperatuuril süljes juba mõne tunni pärast algava bakterite kasvu tõttu soovitatakse süsteemi Salivette® Cortisol pärast proovivõtmist
kindlalt suletuna kas 4 h jooksul tsentrifuugida ja analüüsida või seda kuni edasise töötlemiseni külmikus hoida.

3URRYLYĄWPLQHMDNËLWOHPLQH
ENNE SÜLJEPROOVI VÕTMIST LUGEGE SEE DOKUMENT TÄIELIKULT LÄBI.
Proovivõtmiseks vajalik töömaterjal:
1.

Kindad, kittel, silmakaitse või muu sobiv kaitseriietus kaitseks sülje kaudu ülekantavate patogeenide või potentsiaalselt nakkuslike materjalide eest.

2.

Süsteemide Salivette® Cortisol arv arsti nõudmisel.

3.

7ËLWNHLQIRSURRYLLGHQWLıWVHHULPLVHNV HWLNHWLO 

23

ET
Proovivõtmine– 60 min – 50

– 40

– 30

– 20

– 10 min

0

2 min ilma
närimisliigutuseta
1–5 s

HƴO

2 min
bƅJ

Proov

JäägidSüljeproovi tuleb võtta kõige varem 60 minutit pärast söömist (vedela/tahke toidu tarbimist), hammaste pesemist või ravimite suukaudset võtmist, et vältida sülje saastumist muude ainetega. Kuni 10 minutit enne
proovivõtmist loputage suud 1–5 sekundit veega.
Vahetult enne süljeproovi võtmist peske ja kuivatage käed.
Võtke vatirull avatud süsteemist Salivette® Cortisol kahe sõrmega tagumisest otsast hoides välja japange suhu.
Vatirull peaks jääma suhu (nt põsetaskusse) 2 minutiks ilma närimisliigutusteta. Minimaalne võetav süljekogus peaks olema 500 μl. Äärmiselt vähese süljeerituse korral jäetakse vatirull pikemaks ajaks suhu.
Võtke vatirull kahe sõrmega tagumisest otsast hoides suust välja ning
pange see vahetult süsteemi Salivette® Cortisol ja sulgege sinise korgiga.
Patsiendile: Süljeproovi tagastamiseks tihedalt suletud süsteemis Salivette® Cortisol järgige arsti juhiseid ning kasutage arsti antud sekundaarset mahutit ja saatmiskarpi/-kotti. Juhul kui ei tagastata kohe, siis
hoidke süsteemi Salivette® Cortisol külmikus.
Arstile ja laborile
Toatemperatuuril süljes juba mõne tunni pärast algava bakterite kasvu tõttu soovitatakse süsteemi Salivette®&RUWLVROSËUDVWSURRYLYĄWPLVWNLQGODOWVXOHWXQDNDVKMRRNVXObƅJMXXUHVPLQXWLWWVHQWULIXXJLGD
ja analüüsida või kuni edasise töötlemiseni külmikus hoida.
Pärast tsentrifuugimist võtke sissepandav nõu, kaasa arvatud kork, läbipaistvast terava põhjaga plastnõust välja.
Plastnõu tipu õnaruses olevate jääkide kohal on edasiseks analüüsiks puhas sülg.
Pärast analüüsi visake terava põhjaga plastnõu ja sissepandav nõu kogumismahutisse.

-ËËWPHNËLWOXVşNHKWLEDUVWLMDODERULNRKWD
1.

Järgida tuleb üldisi hügieenisuuniseid ning õigusaktide sätteid nakkusliku materjali nõuetekohase jäätmekäitluse kohta ja neist tuleb kinni pidada.

2.

Ühekordselt kasutatavad kindad takistavad seejuures nakatumise riski.

3.

Saastunud või täidetud süsteemid Salivette® Cortisol tuleb visata ohtlike bioloogiliste materjalide jaoks mõeldud sobivasse kogumismahutisse, mida saab seejärel autoklaavida ja ära põletada.

4.

Jäätmekäitlus peab toimuma sobivas põletusrajatises või autoklaavimise (aursteriliseerimise) teel.

24

ET
Kirjandus
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Sümbolite ja märgistuste võtiArtikli number

Partii numberKõlblik kuni

CE-märgis

In vitro diagnostikavahend

Järgige kasutusjuhendit

Taaskasutamise korral: saastumisoht

Hoidke päikesevalguse eest kaitstult

Ladustage kuivas kohas

TootjaTootjariik

Tehnilised muudatused on võimalikud.
Kõigist tootega seotud ohujuhtumitest tuleb teavitada tootjat ja pädevat riiklikku asutust.

25

Mode d’emploi – SARSTEDT Salivette® Cortisol

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La Salivette®&RUWLVROHVWXQUÜFLSLHQWSRXUÜFKDQWLOORQVGHVDOLYH(OOHHVWGHVWLQÜHDXUHFXHLODXWUDQVSRUWDXWUDLWHPHQWHWDXVWRFNDJHGHODVDOLYHHQYXHGHODGÜWHUPLQDWLRQGLDJQRVWLTXHin vitro du cortisol. Le produit
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La Salivette®&RUWLVROVHFRPSRVHGŖXQWXEHHQSODVWLTXHWUDQVSDUHQWÇIRQGFRQLTXHGŖXQWXEHVXVSHQGXGŖXQWDPSRQDEVRUEDQWHWGŖXQERXFKRQEOHX

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2.

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3.

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Ne plus utiliser la Salivette®&RUWLVROVLODGDWHGHSÜUHPSWLRQHVWGÜSDVVÜH/DGXUÜHGHFRQVHUYDWLRQGHOD6DOLYHWWH®&RUWLVROSUHQGıQOHGHUQLHUMRXUGXPRLVHWGHOŖDQQÜHLQGLTXÜV

Stockage
La Salivette®&RUWLVROGRLWÝWUHVWRFNÜHÇWHPSÜUDWXUHDPELDQWHDYDQWXWLOLVDWLRQ

Transport/HSURGXLWSHXWÝWUHWUDQVSRUWÜPDQXHOOHPHQWDXVHLQGHOŖÜWDEOLVVHPHQWRXDYHFXQUÜFLSLHQWVHFRQGDLUHFRQIRUPHÇOŖ$'5 LQVWUXFWLRQGŖHPEDOODJH3 3RXUOHWUDQVSRUWGŖÜFKDQWLOORQVGDQVOD6DOLYHWWH® Cortisol, il est
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1.

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infectieuses.

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3.

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2.

/HVJDQWVÇXVDJHXQLTXHOLPLWHQWOHULVTXHGŖLQIHFWLRQ

3.

La Salivette®&RUWLVROFRQWDPLQÜHRXUHPSOLHGRLWÝWUHÜOLPLQÜHGDQVXQUÜFLSLHQWDSSURSULÜSRXUOŖÜOLPLQDWLRQGHVXEVWDQFHVELRORJLTXHVGDQJHUHXVHVTXLSHXWHQVXLWHÝWUHDXWRFODYÜHWLQFLQÜUÜ

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27

FR5ÜIÜUHQFHVELEOLRJUDSKLTXHVSARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)&OÜVGHV\PEROHHWGŖLGHQWLıFDWLRQb

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28

Uputa za upotrebu – SARSTEDT Salivette® Cortisol

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1.

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3.

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35,-(32q(7.$35,.83/-$1-$6/,1(8&,-(/267,352q,7$-7(29$-'2.80(17Materijal potreban za uzimanje uzoraka:
1.

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2.

2GJRYDUDMXÓXNROLÕLQX6$567('76DOLYHWWH®&RUWLVROSUHPDXSXWLOLMHÕQLND

3.

3RSXQLWHSRGDWNH]DLGHQWLıNDFLMXX]RUND QDQDOMHSQLFL 

29

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Uzimanje uzorka- 60 min

- 50

- 40

- 30

- 20

- 10 min0PLQEH]ĭYDNDQMD
1–5s

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2 min
1000 x g

UzorakTalog

6OLQXWUHEDX]HWLQDMUDQLMHPLQXWDQDNRQREURND X]LPDQMDWHNXÓHNUXWHKUDQH SUDQMD]XELLOLX]LPDQMDOLMHNRYDNUR]XVWDNDNRELVHVSULMHÕLODNRQWDPLQDFLMDVOLQHQHSRĭHOMQLPWYDULPD'RPLQXWDSULMHX]LPDQMD
uzorka treba vodom isprati usta u trajanju od 1 do 5 sekundi.
Neposredno prije uzimanja sline operite i osušite ruke.
Tampon izvadite iz otvorene SARSTEDT Salivette®&RUWLVROSULKYDWLYđLJDVGYDSUVWD]DVWUDĭQMLNUDML
stavite ga u usta.
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7DPSRQL]YDGLWHL]XVWDSULKYDWLYđLJDVGYDSUVWD]DVWUDĭQMLNUDM
odmah ga utaknite u SARSTEDT Salivette®&RUWLVROL]DWYRULWHHSUXYHWXELMHOLPÕHSRPZa pacijenta:=DSUHGDMXX]RUNDVOLQHXÕYUVWR]DWYRUHQRMHSUXYHWL6DOLYHWWH®&RUWLVROSRVWXSLWHSUHPDXSXWDPDOLMHÕQLNDLXSRWULMHELWHVHNXQGDUQLVSUHPQLNLNXWLMXYUHÓLFX]DVODQMHNRMXYDPMHGDROLMHÕQLN$NRuzorak ne predajete odmah, pohranite SARSTEDT Salivette® Cortisol u hladnjak.
=DOLMHÕQLNDLODERUDWRULM
,]UD]ORJDđWRYHÓQDVREQRMWHPSHUDWXULQDNRQQHNROLNRVDWLSRÕLQMHUDVWEDNWHULMDXVOLQLSUHSRUXÕXMHVH6$567('76DOLYHWWH®&RUWLVROQDNRQX]LPDQMDX]RUNDÕYUVWR]DWYRUHQXXURNXRGVDWDFHQWULIXJLUDWLQD
1000 x g u trajanju od 2 minute i analizirati ili odmah pohraniti u hladnjak do daljnje obrade.
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8NRQXVQRPGQXSODVWLÕQRJVSUHPQLNDQDOD]LVHÕLVWDVOLQD]DGDOMQMXDQDOL]XL]QDGWDORJDNRMLVHQDOD]LXUH]HUYRDUXNRQXVQRJGQD
1DNRQDQDOL]H]EULQLWHSODVWLÕQLVSUHPQLNVDNRQXVQLPGQRPLXPHWQXWLVSUHPQLNXVSUHPQLN]D]DEULQMDYDQMH

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1.

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2.

Jednokratne rukavice smanjuju rizik od infekcije.

3.

Kontaminirana ili napunjena epruveta Salivette®&RUWLVROPRUDVHRGORĭLWLXRGJRYDUDMXÓLVSUHPQLN]D]EULQMDYDQMHELRORđNLRSDVQRJRWSDGDNRMLVHSRWRPPRĭHDXWRNODYLUDWLLOLVSDOLWL

4.

Zbrinjavanje se mora obaviti u prikladnoj spalionici ili postupkom autoklaviranja (sterilizacije parom).

30

HR
Literatura
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Objašnjenja simbola i oznaka:

Broj artikla

Broj serije

Upotrijebiti do

Oznaka CE

In vitroGLMDJQRVWLÕNLSURL]YRG

Pogledati upute za uporabu

Kod ponovne uporabe: rizik od kontaminacije

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Használati utasítás – SARSTEDT Salivette® Cortisol

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A beteg számára:
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32

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0LQWDYÜWHO
- 60 perc - 50

- 40

- 30

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0

2 perc rágó mozgásQÜONĞO
1-5 mp.

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tegye a szájába.
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33

HUIrodalom
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

6]LPEĂOXPRNÜVMHOąOÜVHNPDJ\DUÈ]DWD

Cikkszám*\ÈUWÈVLWÜWHOV]ÈP

Lejárat napja:&(MHOąOÜV

In vitro diagnosztikai orvostechnikai eszköz

Olvassa el a használati utasítást!

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Száraz helyen tartandó

Gyártó

Gyártási ország

A technikai változtatások jogát fenntartjuk.
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34

Istruzioni d'uso - Salivette® Cortisol SARSTEDT

IT

Destinazione d'uso
Salivette®&RUWLVROÛXQFRQWHQLWRUHSHUFDPSLRQLGLVDOLYDHVHUYHDUDFFRJOLHUHWUDVSRUWDUHPDQLSRODUHHFRQVHUYDUHODVDOLYDSHUOHDQDOLVLGLDJQRVWLFKHin-vitroGLFRUWLVROR,OSURGRWWRÛGHVWLQDWRDOO XVRLQXQDPELHQWH
professionale, da parte di personale medico e di laboratorio preparato.

Descrizione del prodotto
Il sistema Salivette®&RUWLVROÛFRVWLWXLWRGDXQFRQWHQLWRUHLQSODVWLFDWUDVSDUHQWHFRQIRQGRDSXQWDXQLQVHUWRXQWDPSRQHHXQWDSSREOX

51.1534.500=

Contenitore inplastica+

Inserto+Tampone+Tappo blu,VWUX]LRQLGLVLFXUH]]DHDYYHUWHQ]H
1.

,OSURGRWWRQRQGHYHHVVHUHXWLOL]]DWRSHUEDPELQLGLHWÇLQIHULRUHDWUHDQQLRSHUVRQHFRQULVFKLRGLLQJHVWLRQHHOHYDWR

2.

Precauzioni generali: Indossare guanti e altri dispositivi di protezione individuale generali per proteggersi da una possibile esposizione a materiale potenzialmente infettivo. Attenersi alle direttive e alle procedure di
sicurezza del proprio istituto.

3.

La saliva prelevata e manipolata con Salivette® Cortisol non deve essere nuovamente reintrodotta nell'organismo umano.

4.

Non utilizzare una Salivette® Cortisol dopo la data di scadenza. Il periodo di conservazione di una Salivette® Cortisol termina l'ultimo giorno del mese e dell'anno indicati.

&RQVHUYD]LRQHPrima dell’utilizzo conservare la Salivette® Cortisol a temperatura ambiente.

TrasportowSRVVLELOHWUDVSRUWDUHLQWHUQDPHQWHLOSURGRWWRDPDQRRSSXUHLQVLHPHDXQFRQWHQLWRUHVHFRQGDULRFRQIRUPHDOODUHJRODPHQWD]LRQHb$'5 LVWUX]LRQHGLLPEDOODJJLR3 3HULOWUDVSRUWRGLFDPSLRQLGL6DOLYHWWH®
Cortisol si consiglia il contenitore per spedizioni conforme alla regolamentazione ADR (istruzione di imballaggio P650), n. art. 78.898 con inserto assorbente più tappo a vite n. art. 65.679 e una scatola/borsa da
spedizione.
Per il paziente:
Attenersi alle istruzioni del medico relative alla restituzione del campione di saliva nella Salivette® Cortisol ben chiusa e utilizzare il contenitore secondario messo a disposizione dal medico e la scatola/busta per laspedizione. Se non viene restituita immediatamente, conservare la Salivette® Cortisol in frigorifero.

Limitazioni
Il prelievo di saliva dovrebbe avvenire come minimo 60 minuti dopo un pasto (assunzione di sostanze solide/liquide), la pulizia dei denti o l’assunzione orale di medicinali per evitare la contaminazione della saliva con
sostanze che possono interferire.
La durata e la temperatura di conservazione dipendono dal periodo di conservazione del parametro da esaminare. Pertanto, anche a fronte della crescita batterica che a temperatura ambiente ha inizio nella saliva
JLÇGRSRDOFXQHRUHVLFRQVLJOLDGLFKLXGHUHVDOGDPHQWHOD6DOLYHWWH® Cortisol dopo il prelievo del campione e di centrifugarla entro 4 h e analizzarla oppure di conservarla direttamente in frigorifero fino all'ulteriore
lavorazione.

3UHOLHYRHPDQLSROD]LRQHGHOFDPSLRQH
PRIMA DI PROCEDERE AL PRELIEVO DELLA SALIVA, LEGGERE FINO IN FONDO QUESTO DOCUMENTO.
Materiale di lavoro necessario per il prelievo del campione:1.

Guanti, camici, protezioni per gli occhi o altri indumenti protettivi appropriati per proteggersi da agenti patogeni trasmessi con la saliva o materiali potenzialmente infettivi.

2.

Numero di Salivette® Cortisol secondo le indicazioni del medico.

3.

5LHPSLUHOHLQIRUPD]LRQLVXOOŖLGHQWLıFD]LRQHGHOFDPSLRQH VXOOŖHWLFKHWWD 

35

ITPrelievo del campione- 60 min

- 50

- 40

- 30

- 20

- 10 min

0

2 min. senza
movimenti
masticatori.

1-5 secHƴO

2 min
1.000 x g

Campione

Residui

Il prelievo di saliva dovrebbe avvenire come minimo 60 minuti dopo un pasto (assunzione di sostanze solide/liquide), la pulizia dei denti o l’assunzione orale di medicinali per evitare la contaminazione della saliva
con sostanze che possono interferire. Risciacquare la bocca con acqua per 1 -5 secondi nei 10 minuti precedenti al prelievo del campione.
Pulire la mani e asciugarle subito dopo il prelievo di saliva.
Dalla Salivette®&RUWLVRODSHUWDSUHQGHUHLOWDPSRQHFRQGXHGLWDVXOOŖHVWUHPLWÇSRVWHULRUHH
metterlo in bocca.
/DVFLDUHLQERFFD DGHVDOOŖLQWHUQRGHOODJXDQFLD LOWDPSRQHSHUPLQXWLVHQ]DPRYLPHQWLPDVWLFDWRUL/DTXDQWLWÇPLQLPDGLVDOLYDSUHOHYDWDGHYHHVVHUHSDULDGDOPHQRbƐO1HOFDVRLQFXLODVDOLYDVLIRUPLLQ
modo molto modesto, lasciare il tampone in bocca più a lungo.
3UHQGHUHLOWDPSRQHGDOODERFFDFRQGXHGLWDVXOOŖHVWUHPLWÇSRVWHULRUHH
inserirlo direttamente nella Salivette® Cortisol chiudendo poi con il tappo blu.
Per il paziente: Attenersi alle istruzioni del medico relative alla restituzione del campione di saliva nella Salivette® Cortisol ben chiusa e utilizzare il contenitore secondario messo a disposizione dal medico e lascatola/busta per la spedizione. Se non viene restituita immediatamente, conservare la Salivette® Cortisol in frigorifero.
Per medico e laboratorio:$IURQWHGHOODFUHVFLWDEDWWHULFDFKHDWHPSHUDWXUDDPELHQWHKDLQL]LRQHOODVDOLYDJLÇGRSRDOFXQHRUHVLFRQVLJOLDGLFKLXGHUHVDOGDPHQWHOD6DOLYHWWH® Cortisol dopo il prelievo del campione e di centrifugarla entro
4 h a 1.000 x g per 2 minuti e analizzarla oppure di conservarla direttamente in frigorifero fino all'ulteriore lavorazione.
Dopo la centrifugazione togliere l’inserto con il tappo dal contenitore in plastica con fondo a punta.
Nel fondo a punta del contenitore in plastica si trova la saliva pura per l’ulteriore analisi dei resti che si trovano nel serbatoio del fondo a punta.
Dopo l’analisi smaltire il contenitore in plastica con fondo a punta e l’inserto in un apposito contenitore per rifiuti.

Smaltimento - per medico e laboratorio:1.

È necessario attenersi alle linee guida generali sull'igiene e alle disposizioni di legge per il corretto smaltimento del materiale infettivo.

2.

I guanti monouso prevengono il rischio di infezione.

3.

La Salivette® Cortisol contaminata o riempita deve essere smaltita in un apposito contenitore per materiali a rischio biologico, che può poi essere sterilizzato in autoclave e incenerito.

4.

/RVPDOWLPHQWRGHYHHVVHUHHĳHWWXDWRLQXQLQFHQHULWRUHDGDWWRRFRQO DXWRFODYH VWHULOL]]D]LRQHDYDSRUH 

36IT%LEOLRJUDıDSARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Legenda dei simboli e dei contrassegni:

Codice articolo

Designazione della partita

Usare entro

Marchio CE

Diagnostica in vitro

Attenersi alle istruzioni d'uso

In caso di riutilizzo: rischio di contaminazione

Conservare al riparo dalla luce del sole

Conservare in un luogo asciutto

Produttore

Paese di fabbricazione

Con riserva di modifiche tecniche.
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SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

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LT

1DXGRMLPRSDVNLUWLV„Salivette®&RUWLVROŗPâJLQWXYâOLVVHLOLģPâJLQLDPV\UDVNLUWDVSDLPWLJDEHQWLDSGRURWLLUODLN\WLVHLOLģPâJLQLXVNRUWL]ROLRin-vitro diagnostiniams tyrimams. Produktas skirtas naudoti profesionalioje aplinkoje ir sveikatos
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Gaminio aprašymas
„Salivette®&RUWLVROŗVXVLGHGDLđVNDLGUDXVSODVWLNLQLRPâJLQWXYâOLRVPDLOLXGXJQXSDNDELQDPRPâJLQWXYâOLRVLXUELPRULWLQâOLRLUPâO\QRNDPđÕLR51.1534.500=

plastikinis
PâJLQWXYâOLV+pakabinamas
PâJLQWXYâOLV+VLXUELPRULWLQâOLV+PâO\QDVNDPđWLV

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1.

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4.

Nenaudokite „Salivette® Cortisol“ pasibaigus galiojimo laikui. „Salivette®&RUWLVROŗJDOLRMLPRODLNDVEDLJLDVLSDVNXWLQãQXURG\WRPâQHVLRLUPHWģGLHQÐ

Laikymas„Salivette®&RUWLVROŗSULHđQDXGRMLPÐWXULEğWLODLNRPDVNDPEDULRWHPSHUDWğURMH

Gabenimas*DPLQòJDOLPDSHUQHđWLUDQNLQLXEğGXNDLMLVVNLUWDVQDXGRWLYLGXMHDUEDJDEHQWLNDUWXVX$'5 SDNXRWâVLQVWUXNFLMD3 DWLWLQNDQÕLXDQWULQLXLQGXŚ6DOLYHWWH®&RUWLVROŗPâJLQLDPVJDEHQWLUHNRPHQGXRMDPDQDXGRWL$'5
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Pacientams:
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laikykite „Salivette® Cortisol“ šaldytuve.

$SULERMLPDL
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1.

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2.

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3.

8ĭSLOG\NLWHPâJLQLRLGHQWLıNDYLPRLQIRUPDFLMÐ HWLNHWâMH 41LT0âJLQLRSDâPLPDV- 60 min. - 50

- 40

- 30

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0

2 min. be kramtymo
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1000 x g0âJLQ\V/LNXÕLDL

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Prieš pat rinkdami seiles, nusiplaukite ir nusausinkite rankas.
3DLPNLWHVLXUELPRULWLQâOòXĭJDOLQâVSXVâVGYLHPSLUđWDLVLđWUDXNLWHMòLđDWLGDU\WRŚ6DOLYHWWH® Cortisol“ iròVLGâNLWHòEXUQÐ/DLN\NLWHVLXUELPRULWLQâOòEXUQRMHPLQXWHVEXUQRMH SY]XĭNLđWÐXĭVNUXRVWR QHNUDPW\GDPL0DĭLDXVLDVVHLOLģNLHNLVNXUòUHLNLDSDLPWLWXULEğWLƐO-HLVHLOâWHNLVODEDLPDĭDVSDOLNLWHVLXUELPRULWLQâOòEXUQRMH
ilgiau.
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Pacientams:1RUâGDPLJUÐĭLQWLVHLOLģPâJLQòòVDQGDULDLXĭGDU\WÐŚ6DOLYHWWH®&RUWLVROŗODLN\NLWâVJ\G\WRMRQXURG\PģLUQDXGRNLWHJ\G\WRMRSDWHLNWÐDQWULQãWDOS\NOÐEHLJDEHQLPRGâĭXWãPDLđHOò-HLLđNDUWRPâJLQLR
LđVLģVWLQHJDOâVLWHODLN\NLWHŚ6DOLYHWWH® Cortisol“ šaldytuve.
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min. per 4 valandas arba laikyti šaldytuve iki tolesnio apdorojimo.
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42LT/LWHUDWğUD
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

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Partijos pavadinimas

Tinka naudoti iki&(ĭHQNODVIn vitro diagnostikai/DLN\WLVQDXGRMLPRLQVWUXNFLMģ

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Laikyti sausoje vietoje

Gamintojas

Pagaminimo šalis

Galimi techniniai pakeitimai.
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43

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Salivette®&RUWLVROLUSDUDXJXWUDXNVVLHNDOXSDUDXJLHPXQWRL]PDQWRVLHNDOXSDÿHPđDQDLWUDQVSRUWàđDQDLDSVWUÌGHLXQX]JODEÌđDQDLin vitroGLDJQRVWLVNDLNRUWL]RODQRWHLNđDQDL,]VWUÌGÌMXPVSDUHG]àWVOLHWRđDQDLSURIHVLRQÌOÌYLGàXQWRGUñNVWOLHWRWPHGLFñQDVVSHFLÌOLVWLXQODERUDWRULMXSHUVRQÌOV,]VWUÌGÌMXPDDSUDNVWVSalivette®&RUWLVROVDVWÌYQRFDXUVSñGñJDSODVWPDVDVWUDXNDDUVPDLOXSDPDWXSLHNDULQDPDWUDXNDVğNđDQDVUXùùDXQ]LODDL]EÌ]ÿD

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2.

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LV/LWHUDWğUD
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

6LPEROXXQDS]ñPàMXPXVNDLGURMXPVArtikula numurs

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Gebruiksaanwijzing - SARSTEDT Salivette® Cortisol

NL

Gebruiksdoel
De Salivette® Cortisol is een monsterbuisje voor speekselmonsters en wordt gebruikt voor de afname en het transporteren, verwerken en opslaan van speeksel voor de in-vitro diagnostische bepaling van cortisol. Het
product is bestemd voor gebruik in een professionele omgeving en door gespecialiseerd medisch personeel en laboratoriumpersoneel.

3URGXFWEHVFKULMYLQJ
De Salivette® Cortisol bestaat uit een transparant kunststof buisje met spitse bodem, een inhangbuisje, een wattenrolletje en een blauwe dop.

51.1534.500=

Kunststof buisje+

Inhangbuisje+

Wattenrolletje+

blauwe dop

Veiligheidsinstructies en waarschuwingen
1.

+HWSURGXFWPDJQLHWZRUGHQJHEUXLNWELMNLQGHUHQMRQJHUGDQGULHMDDURIELMSDWLßQWHQPHWHHQYHUKRRJGULVLFRRSYHUVOLNNLQJ

2.

Algemene voorzorgsmaatregelen: Gebruik handschoenen en andere algemene persoonlijke beschermingsmiddelen ter bescherming tegen mogelijke blootstelling aan potentieel infectieuze monsters. De
veiligheidsrichtlijnen en -procedures van uw instelling moeten altijd worden opgevolgd.

3.

Speeksel dat met de Salivette® Cortisol gewonnen en verwerkt is, is niet bestemd om terug in het menselijke lichaam te worden gebracht.

4.

Een Salivette® Cortisol na het verstrijken van de houdbaarheidsdatum niet meer gebruiken. De houdbaarheid van een Salivette® Cortisol eindigt op de laatste dag van de aangegeven maand en jaar.

BewarenDe Salivette® Cortisol moet voor gebruik bij kamertemperatuur worden bewaard.

Transport
Het product kan samen met een secundaire recipiënt die voldoet aan de ADR (verpakkingsinstructie P650) worden getransporteerd. Om het monster van de Salivette® Cortisol te transporteren, wordt detransportcontainer art. nr. 78.898, die voldoet aan de ADR (verpakkingsinstructie P650), met absorptie materiaal plus schroefdop art. nr. 65.679 en een transportdoos/zak aanbevolen.
Voor patiënt:Respecteer voor het terugbrengen van het speekselmonster in de vast gesloten Salivette® Cortisol de aanwijzingen van de arts en gebruik de secundaire recipiënt en de verzendbox/-zak die door de arts ter beschikking
worden gesteld. Als het terugbrengen niet direct gebeurt, bewaar de Salivette® Cortisol dan in de koelkast.

Beperkingen
De speekselafname mag pas 60 minuten na een maaltijd (vloeibare/vaste voedingsopname), het poetsen van de tanden of orale inname van medicijnen gebeuren, om een contaminatie van het speeksel door storende
substanties te vermijden.
De bewaartijd en -temperatuur zijn afhankelijk van de houdbaarheid van de te onderzoeken parameters. Om deze reden en vanwege de bacteriegroei in speeksel die al na enkele uren bij kamertemperatuur begint, wordt
aanbevolen de Salivette® Cortisol na monstername goed afgesloten ofwel binnen de 4 u te centrifugeren en te analyseren ofwel direct tot verdere verwerking in de koelkast te bewaren.

Monstername en gebruik
LEES DIT DOCUMENT VOLLEDIG VOORDAT U MET DE SPEEKSELWINNING BEGINT.
Benodigdheden voor de monstername:1.

Handschoenen, jas, oogbescherming of andere geschikte veiligheidskleding ter bescherming tegen door speeksel overgedragen pathogenen of mogelijk infectieus materiaal.

2.

Aantal Salivette® Cortisol conform vereiste van de arts.

3.

9XOGHLQIRUPDWLHRPWUHQWPRQVWHULGHQWLıFDWLH RSHWLNHW LQ

47

NL
Monsterafname- 60 min

- 50

- 40

- 30

- 20

- 10 min

0

2 min zonder
kauwbeweging
1-5 secHƴO

2 min
1.000 x g

Monster

Residuen

De speekselafname mag pas 60 minuten na een maaltijd (vloeibare/vaste voedingsopname), het poetsen van de tanden of orale inname van medicijnen gebeuren, om een contaminatie van het speeksel door
storende substanties te vermijden. Spoel tot 10 minuten voor monsterafname de mond gedurende 5 seconden met water.
Was onmiddellijk voor de speekselafname uw handen en droog ze af.
Neem het wattenrolletje aan het achterste uiteinde met twee vingers uit de geopende Salivette® Cortisol en
plaats het in de mond.
Het wattenrolletje moet gedurende 2 minuten zonder kauwbewegingen in de mond (bijv. wang) blijven zitten. De hoeveelheid te winnen speeksel moet 500 μl zijn. Bij extreem lage speekselvorming kan men het
wattenrolletje langer in de mond laten rusten.
Neem het wattenrolletje aan het achterste uiteinde met twee vingers uit de mond en
steek het onmiddellijk in de puntbuis en sluit deze met de blauwe dop.
Voor patiënt: Respecteer voor het terugbrengen van het speekselmonster in de vast gesloten puntbuis de aanwijzingen van de arts en gebruik de secundaire recipiënt en de verzendbox/-zak die door de arts terbeschikking worden gesteld. Als het terugbrengen niet direct gebeurt, bewaar de Salivette® Cortisol dan in de koelkast.
Voor arts en laboratorium:
Vanwege de bacteriegroei in speeksel die al na enkele uren bij kamertemperatuur begint, wordt aanbevolen de Salivette® Cortisol na monstername goed afgesloten ofwel binnen de 4 u bij 1.000 x g gedurende 2
minuten te centrifugeren en te analyseren ofwel direct tot verdere verwerking in de koelkast te bewaren.
Neem na centrifugatie het inhangbuisje inclusief dop uit het kunststof buisje met spitse bodem:
In de spitse bodem van het kunststof buis bevindt zich het zuivere speeksel voor verdere analyse boven de residuen die zich in het reservoir van de spitse bodem bevinden.
Gooi na analyse het kunststof buisje met spitse bodem en het inhangbuisje in een afvalcontainer.

9HUZLMGHULQJJHOGWYRRUDUWVHQODERUDWRULXP
1.

De algemene hygiënerichtlijnen en de wettelijke bepalingen voor de correcte verwijdering van infectieus materiaal moeten worden nageleefd.

2.

Wegwerphandschoenen voorkomen daarbij het risico op infectie.

3.

Gecontamineerde of gevulde Salivette®&RUWLVROPRHWZRUGHQYHUZLMGHUGLQJHVFKLNWHFRQWDLQHUVYRRUJHYDDUOLMNHELRORJLVFKHVWRĳHQGLHYHUYROJHQVJHDXWRFODYHHUGHQYHUEUDQGNXQQHQZRUGHQ

4.

De verwijdering dient plaats te vinden in een geschikte verbrandingsoven of door middel van autoclaveren (stoomsterilisatie).

48

NL
Literatuur
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Informatie over symbolen en markeringen:

Artikelnummer

Lotnummer

EXP

CE-markering

In-vitro diagnosticum

Gebruikershandleiding opvolgen

Bij hergebruik: Risico op besmetting

Niet blootstellen aan zonlicht

Droog bewaren

FabrikantLand van productie

Technische wijzigingen voorbehouden.
Alle ernstige incidenten met betrekking tot het product moeten worden gemeld aan de fabrikant en de bevoegde nationale instantie.

49

Bruksanvisning – SARSTEDT Salivette® Cortisol

NO

Bruksformål
Salivette® Cortisol er en prøvebeholder for spyttprøver og brukes til å innhente, transportere, bearbeide og oppbevare spytt til in vitro-diagnostiske bestemmelser. Produktet er ment til bruk i profesjonelt miljø av
medisinsk fagpersonell og laboratoriepersonell.

3URGXNWEHVNULYHOVH
Salivette® Cortisol består av en transparent plastbeholder med spiss bunn, en hengebeholder, en oppsugingstampong og en blå propp.

51.1534.500=

plastbeholder+

hengebeholder+

tampong til
oppsuging+blå propp

6LNNHUKHWVPHUNQDGHURJDGYDUVOHU
1.

3URGXNWHWPÎLNNHEUXNHVWLOEDUQXQGHUbÎUHOOHUDYSHUVRQHUPHGIRUKĉ\HWIDUHIRUNYHOQLQJ

2.

Generelle forsiktighetstiltak: Bruk hansker og annet generelt personlig verneutstyr for å beskytte deg mot en mulig eksponering overfor potensielt smittsomt prøvemateriale. Sikkerhetsreglene og -prosessene tilhelseinstitusjonen der du jobber skal følges.

3.

Spyttet som er oppsamlet og bearbeidet med Salivette® Cortisol er ikke ment for tilbakeføring til menneskekroppen.

4.

Salivette® Cortisol skal ikke brukes etter at holdbarhetsdatoen er utløpt. Holdbarheten til en Salivette® Cortisol løper ut den siste dagen i den angitte måneden og det angitte året.

2SSEHYDULQJ
Salivette® Cortisol skal oppbevares ved romtemperatur.

Transport
Produktet kan transporteres manuelt eller sammen med en ADR-samsvarende (pakningsanvisning P650) sekundærbeholder. Til prøvetransport av Salivette® Cortisol anbefales bruk av ADR-samsvarende(pakningsanvisning P650) forsendelsesbeholder med art.nr. 78.898 med sugeinnlegg pluss skrukork med art.nr. 65.679 samt en forsendelsesboks/-pose.
For pasient:
Følg instruksene fra legen for retur av spyttprøven i den forsvarlig lukkede Salivette® Cortisol, og bruk sekundærbeholderen som legen har stilt til disposisjon samt forsendelsesboksen/-posen. Dersom prøven ikke
analyseres med en gang, skal Salivette(r) Cortisol oppbevares i kjøleskapet.

Begrensninger
6S\WWSUĉYHQVNDOWLGOLJVWWDVbPLQXWWHUHWWHUHWPÎOWLG IO\WHQGHIDVWQÑULQJVRSSWDN WDQQSXVVHOOHURUDOWLQQWDNDYPHGLNDPHQWHUGHWWHIRUÎIRUKLQGUHHQNRQWDPLQHULQJDYVS\WWHW
Oppbevaringsvarigheten og -temperaturen avhenger av holdbarheten til parameterne som skal undersøkes. Derfor, og på grunn av bakterieveksten i spyttet, som ved romtemperatur oppstår allerede etter noen timer,
anbefales det at Salivette®&RUWLVROOXNNHVJRGWHWWHUSUĉYHWDNLQJHQRJHQWHQVHQWULIXJHUHVRJDQDO\VHUHVLQQHQbWLPHUHOOHUVHWWHVGLUHNWHLNMĉOHVNDSHWIUHPWLOYLGHUHEHKDQGOLQJ

3UĉYHWDNLQJRJKÎQGWHULQJLES GJENNOM HELE DETTE DOKUMENTET FØR DU STARTER SPYTTOPPSAMLINGEN.
Arbeidsmateriale som behøves til prøvetaking:1.

Hansker, kittel, øyevern eller andre egnede verneklær som beskyttelse mot spyttoverførbare patogener eller potensielt infeksiøst materiale.

2.

Antall Salivette® Cortisol i henhold til kravet fra legen.

3.

)\OOXWLQIRUPDVMRQVRPJMHOGHUSUĉYHLGHQWLıVHULQJHQ SÎHWLNHWW 

50

NO
Prøvetaking
bPLQ

- 50

- 40

- 30

- 20

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0bPLQXWWHUXWHQ
tyggebevegelse
şbV

HƴO

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1000 x g

Prøve

Rester

6S\WWSUĉYHQVNDOWLGOLJVWWDVbPLQXWWHUHWWHUHWPÎOWLG IO\WHQGHIDVWQÑULQJVRSSWDN WDQQSXVVHOOHURUDOWLQQWDNDYPHGLNDPHQWHUGHWWHIRUÎIRUKLQGUHHQNRQWDPLQHULQJDYVS\WWHW,QQWLObPLQXWWHUIĉUSUĉYHQWDVVNDOPXQQHQVN\OOHVPHGYDQQLşbVHNXQGHU
Umiddelbart før prøven tas, skal hendene vaskes og tørkes.
Bruk to fingre, grip oppsugingstampongen i den bakre enden og ta den ut av den åpnede Salivette® Cortisol, og
legg den i munnen.
2SSVXJLQJVWDPSRQJHQVNDOIRUEOLLPXQQHQ IHNVODQJVNLQQHW LbPLQXWWHUXWHQW\JJHEHYHJHOVHU'HWVNDOVDPOHVRSSHQPLQLPXPVS\WWPHQJGHSÎbƐO9HGHNVWUHPWOLWHQVS\WWGDQQHOVHODUPDQWDPSRQJHQ
ligge lengre i munnen.
Ta tampongen ut av munnen ved å gripe i den bakre enden med to fingre,
stikk den øyeblikkelig inn i Salivette® Cortisol og steng med den blå proppen.
For pasient: Følg instruksene fra legen for retur av spyttprøven i den forsvarlig lukkede Salivette® Cortisol, og bruk sekundærbeholderen som legen har stilt til disposisjon, samt forsendelsesboksen/-posen.
Dersom analysen ikke finner sted med en gang, skal Salivette® Cortisol oppbevares i kjøleskapet.
For lege og laboratorium:På grunn av bakterieveksten i spyttet, som ved romtemperatur oppstår allerede etter noen timer, anbefales det at Salivette®&RUWLVROOXNNHVJRGWHWWHUSUĉYHWDNLQJHQRJHQWHQVHQWULIXJHUHVLQQHQbWLPHUYHG
[JLbPLQXWWHURJVÎDQDO\VHUHVHOOHUVHWWHVGLUHNWHLNMĉOHVNDSHWIUHPWLOYLGHUHEHKDQGOLQJ
Etter sentrifugeringen skal hengebeholderen inkludert proppen tas ut av plastbeholderen med den spisse bunnen.
I den spisse bunnen av plastbeholderen finnes det rene spyttet til videre analyse.
Etter analysen skal plastbeholderen med den spisse bunnen og hengebeholderen kasseres i en avfallsbeholder.

$YIDOOVKÎQGWHULQJşJMHOGHUIRUOHJHRJODERUDWRULXP
1.

De generelle retningslinjene for hygiene samt de lovfestede bestemmelsene for forskriftsmessig destruksjon av infeksiøst materiale skal tas hensyn til og overholdes.

2.

Engangshansker forhindrer faren for infeksjon.

3.

Kontaminerte eller fylte Salivette®&RUWLVROPÎGHVWUXHUHVLHJQHGHDYIDOOVEHKROGHUHIRUELRORJLVNHIDUHVWRĳHUVRPGHUHWWHUNDQDXWRNODYHUHVRJIRUEUHQQHV4.

'HVWUXHULQJPÎıQQHVWHGLHWHJQHWIRUEUHQQLQJVDQOHJJHOOHUYKDDXWRNODYHULQJ GDPSVWHULOLVHULQJ 

51

NO
Litteratur
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / «Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol»
Kirschbaum, Hellhammer «Salivary Cortisol», Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Forklaring av symboler og kjennetegn:

Artikkelnummer

Produksjonsnummer

Brukes før

CE-merke

In vitro-diagnostisk middel

Overhold bruksanvisningen

Ved gjenbruk: kontaminasjonsfare

Oppbevares beskyttet mot sollys

Lagres tørt

Produsent

Produksjonsland

Med forbehold om tekniske endringer.
Alle alvorlige hendelser knyttet til produktet skal meldes fra om til produsenten og til ansvarlige nasjonale myndigheter.

52

,QVWUXNFMDREVúXJLşSUREĂZND6DOLYHWWH® Cortisol SARSTEDT

PL

Przeznaczenie
Probówka Salivette®&RUWLVROMHVWQDF]\QLHPQDSUĂENãďOLQ\LVúXĮ\GRSRELHUDQLDWUDQVSRUWXSU]HWZDU]DQLDLSU]HFKRZ\ZDQLDďOLQ\GRR]QDF]HüGLDJQRVW\F]Q\FKin-vitro kortyzolu. Produkt jest przeznaczony do
VWRVRZDQLDZSURIHVMRQDOQ\PďURGRZLVNXSU]H]OHNDU]\VSHFMDOLVWĂZLSHUVRQHOODERUDWRU\MQ\Opis produktu
Probówka Salivette®&RUWLVROVNúDGDVLã]SU]H]URF]\VWHJRQDF]\QLD]WZRU]\ZDV]WXF]QHJR]HVWRĮNRZ\PGQHPQDF]\QLDQD]DZLHVLQãURONLFKúRQQHMRUD]]QLHELHVNLHJRNRUND

51.1534.500=

naczynie z
tworzywa
sztucznego+

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+URONDFKúRQQD

+niebieska
zatyczka:VND]ĂZNLEH]SLHF]HüVWZDLRVWU]HĮHQLD
1.

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2.

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4.

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Przechowywanie
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Transport
3URGXNWWHQQDOHĮ\WUDQVSRUWRZDÓQDWHUHQLHSODFĂZNLZSRMHPQLNXZWĂUQ\P]JRGQ\P]$'5 LQVWUXNFMDSDNRZDQLD3 :FHOXWUDQVSRUWXSUĂEHNZZ\UREDFK6DOLYHWWH®&RUWLVRO]DOHFDVLãVWRVRZDQLHQDF]\QLD
Z\V\úNRZHJR]JRGQHJR]$'5 LQVWUXNFMHSDNRZDQLD3 QUDUW]ZNúDGHPFKúRQQ\PL]DNUãWNÐQUDUWZUD]]SRMHPQLNLHPWRUEÐZ\V\úNRZÐDla pacjenta::FHOXRGGDQLDSUĂENLďOLQ\ZGREU]H]DPNQLãWHMSUREĂZFH6DOLYHWWH®&RUWLVROQDOHĮ\SU]HVWU]HJDÓ]DOHFHüOHNDU]DLXĮ\ÓSRMHPQLNDZ\V\úNRZHJRWRUE\Z\V\úNRZHMRWU]\PDQ\FKZSODFĂZFHVúXĮE\]GURZLD-HďOL]ZURWSUĂENLQLHPRĮHQDVWÐSLÓRGUD]XSRSREUDQLXSUREĂZNã6DOLYHWWH®&RUWLVROQDOHĮ\SU]HFKRZ\ZDÓZORGĂZFH

Ograniczenia
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ZLURZDQLHLDQDOL]RZDQLHSUĂENLPDNV\PDOQLHJRG]LQ\SRSREUDQLXMHMGRV]F]HOQLH]DPNQLãWHMSUREĂZNL6DOLYHWWH® Cortisol lub natychmiastowe przechowywanie w lodówce do czasu analizy.

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1$/(Æ<35=(&=<7$o7(1'2.80(17:&$2¨&,35=('32%5$1,(035%.,¨/,1<
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1.

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Liczba probówek Salivette® Cortisol wymagana przez lekarza.

3.

3RGDÓLQIRUPDFMHXPRĮOLZLDMÐFHLGHQW\ıNDFMãSUĂEHN QDHW\NLHFLH 

53

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- 50

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1.

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3.

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PL3LďPLHQQLFWZRSARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol”
Kirschbaum, Hellhammer „Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

2EMDďQLHQLHV\PEROLLR]QDF]Hü

1XPHUDUW\NXúX

Oznaczenie partii=XĮ\ÓGR

Znak CE

Wyrób medyczny do diagnostyki in-vitro

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ProducentKraj produkcji=PLDQ\WHFKQLF]QH]DVWU]HĮRQH:V]HONLHSRZDĮQHLQF\GHQW\]ZLÐ]DQH]SURGXNWHPQDOHĮ\]JúDV]DÓSURGXFHQWRZLLZúDďFLZHPXRUJDQRZLNUDMRZHPX

55

Instruções de utilização - Salivette® Cortisol SARSTEDTPT$SOLFD×ĄHVO Salivette®&RUWLVROÜXPUHFLSLHQWHGHDPRVWUDSDUDDPRVWUDVGHVDOLYDHVHUYHSDUDDFROKHLWDWUDQVSRUWHWUDWDPHQWRHDUPD]HQDPHQWRGHVDOLYDSDUDGHWHUPLQD×ÊRGHFRUWLVROGHGLDJQĂVWLFRVin-vitro. O produto
GHVWLQDVHDRXVRHPDPELHQWHSURILVVLRQDOHÇDSOLFD×ÊRSRUSHVVRDOPÜGLFRHWÜFQLFRGHODERUDWĂULRHVSHFLDOL]DGRVDescrição do produto
O Salivette®&RUWLVROÜFRPSRVWRSRUXPUHFLSLHQWHGHSOÈVWLFRWUDQVSDUHQWHFRPEDVHSRQWLDJXGDXPUHFLSLHQWHVXVSHQVRXPURORGHDOJRGÊRHXPDWDPSDD]XO

51.1534.500=

Recipiente deplástico+

Recipiente
suspenso+

Rolo de algodão

+Tampa azul

,QVWUX×ĄHVHDYLVRVGHVHJXUDQ×D
1.

2SURGXWRQÊRSRGHVHUXWLOL]DGRSRUFULDQ×DVFRPPHQRVGHDQRVEHPFRPRSRUSDFLHQWHVTXHDSUHVHQWHPULVFRHOHYDGRGHLQJHVWÊR

2.

Precauções gerais: Utilize luvas e outros equipamentos de proteção individual gerais para se proteger de uma possível exposição a material de amostra potencialmente infecioso. As diretrizes e os procedimentos
de segurança da sua instituição devem ser seguidos.

3.

A saliva colhida e processada com o Salivette® Cortisol não se destina a reintegração no corpo humano.

4.

Não reutilizar um Salivette® Cortisol após o prazo de validade. O prazo de validade de um Salivette®&RUWLVROWHUPLQDQRěOWLPRGLDGRPÝVHDQRHVSHFLıFDGRVArmazenamento
O Salivette®&RUWLVROGHYHVHUDUPD]HQDGRÇWHPSHUDWXUDDPELHQWHDQWHVGDVXDXWLOL]D×ÊRTransporte
O produto pode ser transportado manualmente no espaço interior ou juntamente com um recipiente secundário compatível com ADR (instrução de embalagem P650). Para o transporte de amostras do Salivette®
&RUWLVROÜUHFRPHQGDGRRUHFLSLHQWHGHWUDQVSRUWHQųDUWFRPFDPDGDDEVRUYHQWHHWDPSDURVFDGDQųDUWHPFRQIRUPLGDGHFRPD$'5 LQVWUX×ÊRGHHPEDODJHP3 EHPFRPRXPDFDL[DXP
saco de transporte.
Para o paciente:
Para a devolução da amostra de saliva no Salivette®&RUWLVROEHPIHFKDGRVLJDDVLQVWUX×ĄHVGRPÜGLFRHXWLOL]HRUHFLSLHQWHVHFXQGÈULRHDFDL[DRVDFRGHWUDQVSRUWHIRUQHFLGRVSHORPÜGLFR&DVRDGHYROX×ÊRQÊRseja feita diretamente, armazene este Salivette® Cortisol no frigorífico.

/LPLWD×ĄHV
A colheita de saliva deverá ser feita, pelo menos, 60 minutos após uma refeição (ingestão de alimentos líquidos/sólidos), a lavagem dos dentes ou a toma de medicamentos, para evitar uma contaminação da saliva por
substâncias interferentes.
O período e a temperatura de armazenamento dependem do prazo de validade dos parâmetros a serem examinados. Por esta razão e devido ao crescimento bacteriano na saliva, que se inicia logo após algumas
KRUDVÇWHPSHUDWXUDDPELHQWHUHFRPHQGDVHFHQWULIXJDUHDQDOLVDUR6DOLYHWWH®&RUWLVRODSĂVDFROKHLWDGDDPRVWUDEHPIHFKDGDQRHVSD×RGHKRUDVRXDUPD]HQÈORQRIULJRUìILFRDWÜRSURFHVVDPHQWRSRVWHULRU

Amostragem e manuseamento
LEIA ESTE DOCUMENTO INTEGRALMENTE ANTES DE COMEÇAR A COLHEITA DE SALIVA.
Material de trabalho necessário para a colheita da amostra:
1.

/XYDVEDWDSURWH×ÊRRFXODURXRXWUDVURXSDVGHSURWH×ÊRDGHTXDGDVSDUDSURWH×ÊRFRQWUDDJHQWHVSDWRJÜQLFRVWUDQVPLWLGRVSHODVDOLYDRXPDWHULDLVSRWHQFLDOPHQWHLQIHFLRVRV

2.

Quantidade de Salivette®&RUWLVROGHDFRUGRFRPDUHTXLVL×ÊRGRPÜGLFR

3.

3UHHQFKHUDLGHQWLıFD×ÊRGDDPRVWUD QDHWLTXHWD 

56

PT
Colheita de amostra- 60 minutos - 50

- 40

- 30

- 20

- 10 minutos

0

2 minutos sem
movimento demastigação

1-5 seg.

HƴO

2 minutos
1.000 x g

AmostraResíduos

A colheita de saliva deverá ser feita, pelo menos, 60 minutos após uma refeição (ingestão de alimentos líquidos/sólidos), a lavagem dos dentes ou a toma de medicamentos, para evitar uma contaminação da
VDOLYDSRUVXEVWÉQFLDVLQWHUIHUHQWHV$WÜPLQXWRVDQWHVGDFROKHLWDGDDPRVWUDODYDUDERFDFRPÈJXDGXUDQWHVHJXQGRVLavar e secar as mãos imediatamente antes da colheita de saliva.
Remover com dois dedos o rolo de algodão na extremidade traseira do Salivette® Cortisol aberto
e colocar na boca.
O rolo de algodão deve permanecer na boca durante 2 minutos sem movimentos de mastigação (por exemplo, bochecha). A quantidade mínima de saliva a ser colhida deverá ser de 500μl. Em caso de pouca
produção de saliva, o rolo de algodão deverá permanecer na boca por mais tempo.
Remover com dois dedos o rolo de algodão da boca einseri-lo imediatamente no Salivette® Cortisol e fechá-lo com a tampa branca.
Para o paciente: Para a devolução da amostra de saliva no Salivette®&RUWLVROEHPIHFKDGRVLJDDVLQVWUX×ĄHVGRPÜGLFRHXWLOL]HRUHFLSLHQWHVHFXQGÈULRHDFDL[DRVDFRGHWUDQVSRUWHIRUQHFLGRVSHORPÜGLFRCaso a devolução não seja feita diretamente, armazene este Salivette® Cortisol no frigorífico.
3DUDRPÜGLFRHRODERUDWĂULR'HYLGRDRFUHVFLPHQWREDFWHULDQRQDVDOLYDTXHVHLQLFLDORJRDSĂVDOJXPDVKRUDVÇWHPSHUDWXUDDPELHQWHUHFRPHQGDVHFHQWULIXJDUHDQDOLVDUR6DOLYHWWH® Cortisol após a colheita da amostra, bem fechada,
QRHVSD×RGHKRUDVQRFDVRGH[GXUDQWHPLQXWRVRXDUPD]HQÈORQRIULJRUìILFRDWÜRSURFHVVDPHQWRSRVWHULRU
Após a centrifugação, remova o recipiente suspenso com a tampa incluída do recipiente de plástico com fundo pontiagudo.
No fundo pontiagudo do recipiente de plástico, encontra-se a saliva pura para a análise mais aprofundada sobre os resíduos que se encontram no reservatório do fundo pontiagudo.
Após a análise, elimine o recipiente de plástico com fundo pontiagudo e o recipiente suspenso num recipiente de eliminação.

(OLPLQD×ÊRşYÈOLGRSDUDRPÜGLFRHODERUDWĂULR
1.

As diretivas gerais de higiene e as normas legais para a eliminação adequada dos materiais infeciosos devem ser observadas e cumpridas.

2.

Luvas descartáveis impedem o risco de infeção.

3.

O Salivette® Cortisol contaminado ou cheio deve ser eliminado em recipientes de eliminação adequados para substâncias biológicas perigosas, que pode então ser autoclavado e incinerado em seguida.

4.

A eliminação deve ocorrer numa instalação de incineração adequada ou por meio de uma autoclave (esterilização a vapor).

57

PT%LEOLRJUDıDSARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Lista de símbolos e sinais:

1ěPHURGRDUWLJR

1ěPHURGRORWH

Prazo de validade

Marcação CE

Diagnóstico in vitro

Observar as instruções de utilização

Em caso de reutilização: Risco de contaminaçãoArmazenar protegido da luz do sol

Armazenar em local seco

FabricantePaís de fabrico

5HVHUYDGRRGLUHLWRDDOWHUD×ĄHVWÜFQLFDV
7RGRVRVLQFLGHQWHVJUDYHVRFRUULGRVHPFRQWH[WRUHODFLRQDGRFRPSURGXWRGHYHPVHUFRPXQLFDGRVDRIDEULFDQWHHÇVDXWRULGDGHVQDFLRQDLVFRPSHWHQWHV58

,QVWUXFėLXQLGHXWLOL]DUHş6DOLYHWWH® cortizol SARSTEDTRO

6FRSXOXWLOL]ÍULL
Salivette®FRUWL]ROHVWHXQWXESHQWUXSUREHGHVDOLYÍēLHVWHXWLOL]DWSHQWUXFROHFWDUHDWUDQVSRUWXOSUHOXFUDUHDēLGHSR]LWDUHDVDOLYHLSHQWUXVWDELOLUHDin-vitroDGLDJQRVWLFHORUGHFRUWL]RO3URGXVXOHVWHGHVWLQDWXWLOL]ÍULLîQWU
XQPHGLXSURIHVLRQDOGHFÍWUHSHUVRQDOPHGLFDOLQVWUXLWîQDFHVWVFRSēLGHFÍWUHSHUVRQDOGHODERUDWRU

Descrierea produsului
Salivette®FRUWL]ROFRQVWÍGLQWUXQWXEGLQSODVWLFWUDQVSDUHQWFXIXQGDVFXėLWXQWXEVXVSHQGDWRUROÍDEVRUEDQWÍēLXQGRSDOEDVWUX

51.1534.500=

Tub din plastic+

Recipient desuspensie+

5ROÍDEVRUEDQWÍ

+Dop albastru,QGLFDėLLSULYLQGVLJXUDQėDēLDWHQėLRQÍUL
1.

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2.

3UHFDXėLLJHQHUDOH8WLOL]DėLPÍQXēLēLDOWHFKLSDPHQWLQGLYLGXDOJHQHUDOGHSURWHFėLHSHQWUXDYÍSURWHMDîPSRWULYDXQHLSRWHQėLDOHH[SXQHULODRSUREÍSRWHQėLDOLQIHFėLRDVÍ(VWHREOLJDWRULXVÍUHVSHFWDėLGLUHFWLYHOHēL
SURFHGXULOHSULYLQGVLJXUDQėDYDODELOHîQLQVWLWXėLDGYV

3.

6DOLYDSUHOHYDWÍēLSURFHVDWÍFX6DOLYHWWH®FRUWL]ROQXHVWHGHVWLQDWÍSHQWUXUHLQWURGXFHUHDîQFRUSXOXPDQ4.

1XHVWHSHUPLVÍXWLOL]DUHDQLFLXQXLWXE6DOLYHWWH®FRUWL]ROGXSÍH[SLUDUHDWHUPHQXOXLGHYDODELOLWDWH3HULRDGDGHYDODELOLWDWHDXQXLWXE6DOLYHWWH®FRUWL]ROVHîQFKHLHîQXOWLPD]LDOXQLLēLDDQXOXLVSHFLıFDWDepozitare
Salivette®FRUWL]ROVHGHSR]LWHD]ÍODWHPSHUDWXUDFDPHUHL

Transport
3URGXVHOHSRWILWUDQVSRUWDWHPDQXDOîQLQWHULRUXOXQLWÍėLLîPSUHXQÍFXXQWXEVHFXQGDUFRQIRUP$'5 LQVWUXFėLXQLGHDPEDODUH3 3HQWUXWUDQVSRUWXOSUREHORU6DOLYHWWH®FRUWL]ROVHUHFRPDQGÍFRQWDLQHUXOGHWUDQVSRUWFRQIRUP$'5 LQVWUXFėLXQLGHDPEDODUH3 QUDUWFXLQVHUėLHDEVRUEDQWÍSOXVFDSDFILOHWDWQUDUWēLRFXWLHSXQJÍGHWUDQVSRUWPentru pacient:
3HQWUXDUHWXUQDSUREDGHVDOLYÍîQWXEXO6DOLYHWWH®&RUWL]ROîQFKLVHWDQēXUPDėLLQVWUXFėLXQLOHPHGLFXOXLēLXWLOL]DėLWXEXOVHFXQGDUēLFXWLDSXQJDGHWUDQVSRUWIXUQL]DWHGHPHGLF'DFÍUHWXUQDUHDQXHVWHLPHGLDWÍSÍVWUDėLacest tub Salivette®&RUWL]ROîQIULJLGHU

5HVWULFėLL
6DOLYDWUHEXLHSUHOHYDWÍQXPDLGHYUHPHGHGHPLQXWHGXSÍPDVÍ DSRUWGHDOLPHQWHOLFKLGHVROLGH GXSÍVSÍODUHDGLQėLORUVDXDGPLQLVWUDUHDGHPHGLFDPHQWHSHFDOHRUDOÍSHQWUXDHYLWDFRQWDPLQDUHDVDOLYHLFXVXEVWDQėHSHUWXUEDWRDUH
7LPSXOGHGHSR]LWDUHēLWHPSHUDWXUDGHSLQGGHGXUDELOLWDWHDSDUDPHWULORUFDUHWUHEXLHH[DPLQDėL'LQDFHVWPRWLYēLGLQFDX]DFUHēWHULLEDFWHULHQHîQVDOLYÍFDUHîQFHSHGHMDGXSÍFÉWHYDRUHODWHPSHUDWXUDFDPHUHLVH
UHFRPDQGÍFDWXEXO6DOLYHWWH®FRUWL]ROVÍILHîQFKLVHUPHWLFLPHGLDWēLILHVÍVHFHQWULIXJKH]HēLVÍVHDQDOL]H]HîQGHFXUVGHbRUHILHVÍVHGHSR]LWH]HGLUHFWîQIULJLGHUSÉQÍODSUHOXFUDUHDXOWHULRDUÍ

3UHOHYDUHDēLPDQLSXODUHDSUREHORU
&,7,¯,$&(67'2&80(171175(*,0(1$,17('($1&(3(5(&2/7$5($6$/,9(,Material de lucru necesar pentru prelevarea probelor:1.

0ÍQXēLKDODWHHFKLSDPHQWGHSURWHFėLHDRFKLORUVDXDOWHHFKLSDPHQWHGHSURWHFėLHDGHFYDWHSHQWUXSURWHFėLDîPSRWULYDDJHQėLORUSDWRJHQLVDOLYDULVDXDPDWHULDOHORUSRWHQėLDOLQIHFėLRDVH

2.

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&RPSOHWDėL SHHWLFKHWÍ LQIRUPDėLLOHGHLGHQWLıFDUHDSUREHL

59

RO
Prelevare de probe- 60 min

- 50

- 40

- 30

- 20

- 10 min0bPLQXWHIÍUÍPLēFDUH
de mestecare
1-5 secHƴO

2 min
1.000 x g

3UREÍReziduuri

6DOLYDWUHEXLHSUHOHYDWÍQXPDLGHYUHPHGHGHPLQXWHGXSÍPDVÍ DSRUWGHDOLPHQWHOLFKLGHVROLGH GXSÍVSÍODUHDGLQėLORUVDXDGPLQLVWUDUHDGHPHGLFDPHQWHSHFDOHRUDOÍSHQWUXDHYLWDFRQWDPLQDUHDVDOLYHLFXVXEVWDQėHSHUWXUEDWRDUH&OÍWLėLJXUDFXDSÍWLPSGHVHFXQGHFXSÉQÍODPLQXWHîQDLQWHGHSUHOHYDUH
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3HQWUXPHGLFēLODERUDWRU
'LQFDX]DFUHēWHULLEDFWHULHQHîQVDOLYÍFDUHîQFHSHGHMDGXSÍFÉWHYDRUHODWHPSHUDWXUDFDPHUHLVHUHFRPDQGÍFDWXEXO6DOLYHWWH®FRUWL]ROVÍILHîQFKLVHUPHWLFLPHGLDWēLILHVÍVHFHQWULIXJKH]HēLVÍVHDQDOL]H]HîQGHFXUVGHbRUHOD[JWLPSGHbPLQXWHILHVÍVHGHSR]LWH]HGLUHFWîQIULJLGHUSÉQÍODSUHOXFUDUHDXOWHULRDUÍ'XSÍFHQWULIXJDUHîQGHSÍUWDėLGLQWXEXOGHSODVWLFFXIXQGXODVFXėLWUHFLSLHQWXOGHVXVSHQVLHLQFOXVLYGRSXOQIXQGXODVFXėLWDOWXEXOXLGHSODVWLFVDOLYDSXUÍSHQWUXDQDOL]DXOWHULRDUÍHVWHSR]LėLRQDWÍGHDVXSUDUH]LGXXULORUFDUHVHDIOÍîQUH]HUYRUXOIXQGXOXLDVFXėLW'XSÍDQDOL]ÍHOLPLQDėLîQWUXQUHFLSLHQWGHHOLPLQDUHWXEXOGHSODVWLFFXIXQGDVFXėLWēLUHFLSLHQWXOGHVXVSHQVLH(OLPLQDUHDşVHDSOLFÍSHQWUXPHGLFēLODERUDWRU
1.

7UHEXLHUHVSHFWDWHēLXUPDWHGLUHFWLYHOHJHQHUDOHGHLJLHQÍēLGLVSR]LėLLOHOHJDOHSULYLQGHOLPLQDUHDFRUHFWÍFDGHēHXULDPDWHULDOHORULQIHFėLRDVH

2.

0ÍQXēLOHGHXQLFÍIRORVLQėÍSUHYLQULVFXOGHLQIHFėLH3.

Tuburile Salivette®FRUWL]ROFRQWDPLQDWHVDXXPSOXWHWUHEXLHDUXQFDWHîQUHFLSLHQWHDGHFYDWHSHQWUXHOLPLQDUHDVXEVWDQėHORUELRORJLFHSHULFXORDVHFDUHSRWıXOWHULRUDXWRFODYL]DWHēLLQFLQHUDWH

4.

(OLPLQDUHDWUHEXLHVÍDLEÍORFîQWUXQLQFLQHUDWRUDGHFYDWVDXîQDXWRFODYÍ VWHULOL]DUHFXDEXU 

60

RO%LEOLRJUDıH
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol”
Kirschbaum, Hellhammer „Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)/HJHQGDVLPEROXULORUēLDPDUFDMHORU

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Denumire lot

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Marcaj CE

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ȩȼɃɉȼɓɁɉɄɁ
Salivette®ɍɆɊɌɎɄɃɊɇɊɈɋɌɁɀɍɎȼȾɇɛɁɎɍɊȽɊɅɋɌɊȽɄɌɆɏɀɇɛɊȽɌȼɃɒɊȾɍɇɚɉɗɄɍɇɏɂɄɎɀɇɛɍȽɊɌȼɎɌȼɉɍɋɊɌɎɄɌɊȾɆɄɊȽɌȼȽɊɎɆɄɄɑɌȼɉɁɉɄɛɍɇɚɉɗɍɒɁɇɘɚɋɊɍɇɁɀɏɚɕɁɅɀɄȼȿɉɊɍɎɄɆɄɏɌɊȾɉɛɆɊɌɎɄɃɊɇȼȾ
ɇȼȽɊɌȼɎɊɌɉɗɑɏɍɇɊȾɄɛɑȤɃɀɁɇɄɁɋɌɁɀɉȼɃɉȼɓɁɉɊɀɇɛɄɍɋɊɇɘɃɊȾȼɉɄɛȾɋɌɊɐɁɍɍɄɊɉȼɇɘɉɊɅɍɌɁɀɁɆȾȼɇɄɐɄɒɄɌɊȾȼɉɉɗɈɄɍɊɎɌɏɀɉɄɆȼɈɄɈɁɀɄɒɄɉɍɆɄɑɄɇȼȽɊɌȼɎɊɌɉɗɑɏɓɌɁɂɀɁɉɄɅ

ȪɋɄɍȼɉɄɁɋɌɊɀɏɆɎȼ
Salivette®ɍɆɊɌɎɄɃɊɇɊɈɍɊɍɎɊɄɎɄɃɋɌɊɃɌȼɓɉɊɅɋɇȼɍɎɄɆɊȾɊɅɋɌɊȽɄɌɆɄɍɆɊɉɄɓɁɍɆɄɈɀɉɊɈɋɊɀȾɁɍɉɊɅɋɌɊȽɄɌɆɄȼȽɍɊɌȽɄɌɏɚɕɁȿɊȾȼɇɄɆȼɄɍɄɉɁɅɋɌɊȽɆɄ

51.1534.500=

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ɋɌɊȽɄɌɆȼ

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ȭɄɉɛɛɋɌɊȽɆȼ

ȨɁɌɗɋɌɁɀɊɍɎɊɌɊɂɉɊɍɎɄ
1.

ȫɌɊɀɏɆɎɉɁɋɌɁɀɉȼɃɉȼɓɁɉɀɇɛɄɍɋɊɇɘɃɊȾȼɉɄɛɏɀɁɎɁɅɈɇȼɀɔɁɇɁɎɄɋȼɒɄɁɉɎɊȾɍɋɊȾɗɔɁɉɉɗɈɌɄɍɆɊɈɋɌɊȿɇȼɎɗȾȼɉɄɛ

2.

ȪȽɕɄɁɈɁɌɗɋɌɁɀɊɍɎɊɌɊɂɉɊɍɎɄȾɊɄɃȽɁɂȼɉɄɁȾɊɃɈɊɂɉɊȿɊɆɊɉɎȼɆɎȼɍɋɊɎɁɉɒɄȼɇɘɉɊɄɉɐɁɆɒɄɊɉɉɗɈɄɈȼɎɁɌɄȼɇȼɈɄɊȽɌȼɃɒɊȾɄɍɋɊɇɘɃɏɅɎɁɃȼɕɄɎɉɗɁɋɁɌɓȼɎɆɄɄɋɌɊɓɄɁɊȽɕɄɁɍɌɁɀɍɎȾȼ
ɄɉɀɄȾɄɀɏȼɇɘɉɊɅɃȼɕɄɎɗȬɏɆɊȾɊɀɍɎȾɏɅɎɁɍɘɋɌɁɀɋɄɍȼɉɄɛɈɄɀɁɅɍɎȾɏɚɕɄɈɄɀɇɛȞȼɔɁȿɊɏɓɌɁɂɀɁɉɄɛ

3.

ȭɇɚɉȼɍɊȽɌȼɉɉȼɛɄɊȽɌȼȽɊɎȼɉɉȼɛɍɋɊɈɊɕɘɚɍɄɍɎɁɈɗ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɉɁɋɌɁɀɉȼɃɉȼɓɁɉȼɀɇɛɋɊȾɎɊɌɉɊȿɊȾȾɁɀɁɉɄɛȾɊɌȿȼɉɄɃɈɓɁɇɊȾɁɆȼ

4.

ȩɁɄɍɋɊɇɘɃɏɅɎɁ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɋɊɍɇɁɄɍɎɁɓɁɉɄɛɍɌɊɆȼȿɊɀɉɊɍɎɄȭɌɊɆȿɊɀɉɊɍɎɄ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɍɊɊɎȾɁɎɍɎȾɏɁɎɋɊɍɇɁɀɉɁɈɏɀɉɚɏɆȼɃȼɉɉɊȿɊɈɁɍɛɒȼɄȿɊɀȼ

ȱɌȼɉɁɉɄɁ
ȭɄɍɎɁɈɏ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɀɊɁɁɄɍɋɊɇɘɃɊȾȼɉɄɛɍɇɁɀɏɁɎɑɌȼɉɄɎɘɋɌɄɆɊɈɉȼɎɉɊɅɎɁɈɋɁɌȼɎɏɌɁ

ȮɌȼɉɍɋɊɌɎɄɌɊȾɆȼ
ȮɌȼɉɍɋɊɌɎɄɌɊȾɆȼɄɃɀɁɇɄɛɈɊɂɁɎɊɍɏɕɁɍɎȾɇɛɎɘɍɛȾɌɏɓɉɏɚȾɉɏɎɌɄɊɌȿȼɉɄɃȼɒɄɄɄɇɄȾɈɁɍɎɁɍɊȾɎɊɌɄɓɉɗɈɄɋɌɊȽɄɌɆȼɈɄɍɊɊɎȾɁɎɍɎȾɏɚɕɄɈɄɎɌɁȽɊȾȼɉɄɛɈȠȪȫȪȟ ŝȤɉɍɎɌɏɆɒɄɛɋɊɏɋȼɆɊȾɆɁ3Ş ȠɇɛɎɌȼɉɍɋɊɌɎɄɌɊȾɆɄɋɌɊȽ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɌɁɆɊɈɁɉɀɏɁɎɍɛɄɍɋɊɇɘɃɊȾȼɎɘɎɌȼɉɍɋɊɌɎɉɗɅɆɊɉɎɁɅɉɁɌɍɊɊɎȾɁɎɍɎȾɏɚɕɄɅɎɌɁȽɊȾȼɉɄɛɈȠȪȫȪȟ ŝȤɉɍɎɌɏɆɒɄɛɋɊɏɋȼɆɊȾɆɁ3Ş ȦȼɎǂǂɍ
ȼȽɍɊɌȽɄɌɏɚɕɁɅȾɍɎȼȾɆɊɅɄɌɁɃɘȽɊȾɊɅɆɌɗɔɆɊɅȼɌɎǂȼɎȼɆɂɁɎɌȼɉɍɋɊɌɎɉɊɅɆɊɌɊȽɆɊɅ ɆɊɉɎɁɅɉɁɌɊɈ
ȠɇɛɋȼɒɄɁɉɎȼ
ȠɇɛɍɀȼɓɄɋɌɊȽɗɍɇɚɉɗȾɋɇɊɎɉɊɃȼɆɌɗɎɊɅɍɄɍɎɁɈɁ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɍɊȽɇɚɀȼɅɎɁɏɆȼɃȼɉɄɛȾɌȼɓȼɄɋɊɇɘɃɏɅɎɁɍɘɋɌɁɀɊɍɎȼȾɇɁɉɉɊɅȾɌȼɓɊɈȾɎɊɌɄɓɉɊɅɋɌɊȽɄɌɆɊɅɄɎɌȼɉɍɋɊɌɎɉɊɅɆɊɌɊȽɆɊɅ ɆɊɉɎɁɅɉɁɌɊɈȡɍɇɄɋɌɊȽɄɌɆɄɍɊȽɌȼɃɒȼɈɄɊɎɋɌȼȾɇɛɚɎɍɛɉȼɄɍɍɇɁɀɊȾȼɉɄɁɉɁɍɌȼɃɏ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɍɇɁɀɏɁɎɑɌȼɉɄɎɘȾɑɊɇɊɀɄɇɘɉɄɆɁ

ȪȿɌȼɉɄɓɁɉɄɛ
ȭȽɊɌɍɇɚɉɗɍɇɁɀɏɁɎɋɌɊȾɊɀɄɎɘɉɁɌȼɉɁɁɓɁɈɓɁɌɁɃɈɄɉɏɎɋɊɍɇɁɓɄɍɎɆɄɃɏȽɊȾɋɌɄɁɈȼɋɄɕɄ ɂɄɀɆɊɅɎȾɁɌɀɊɅ ɄɇɄɋɁɌɊɌȼɇɘɉɊȿɊɋɌɄɁɈȼɇɁɆȼɌɍɎȾȾɊɄɃȽɁɂȼɉɄɁɃȼȿɌɛɃɉɁɉɄɛɍɇɚɉɗɋɊɍɎɊɌɊɉɉɄɈɄ
ȾɁɕɁɍɎȾȼɈɄ
ȭɌɊɆɄɎɁɈɋɁɌȼɎɏɌȼɑɌȼɉɁɉɄɛɃȼȾɄɍɛɎɊɎɍɌɊɆȼȿɊɀɉɊɍɎɄɋɌɁɀɏɍɈɊɎɌɁɉɉɊȿɊɀɇɛɄɍɍɇɁɀɏɁɈɗɑɋȼɌȼɈɁɎɌɊȾȞɍȾɛɃɄɍəɎɄɈɄɄɃɃȼɎɊȿɊɓɎɊɋɌɄɆɊɈɉȼɎɉɊɅɎɁɈɋɁɌȼɎɏɌɁɌɊɍɎȽȼɆɎɁɌɄɅȾɍɇɚɉɁɉȼɓɄɉȼɁɎɍɛ
ɏɂɁɓɁɌɁɃɉɁɍɆɊɇɘɆɊɓȼɍɊȾɌɁɆɊɈɁɉɀɏɁɎɍɛɋɊɍɇɁɍȽɊɌȼɋɌɊȽɗɋɌɊȾɁɍɎɄɒɁɉɎɌɄɐɏȿɄɌɊȾȼɉɄɁɄȼɉȼɇɄɃ6DOLYHWWH®ȾɎɁɓɁɉɄɁɓȼɍɊȾɄɇɄɑɌȼɉɄɎɘɋɌɊȽɏȾɑɊɇɊɀɄɇɘɉɄɆɁɀɊɋɊɍɇɁɀɏɚɕɁɅɊȽɌȼȽɊɎɆɄ

ȭȽɊɌɄɊȽɌȼȽɊɎɆȼɋɌɊȽ
ȫȪȧȩȪȭȮȸȺȫȬȪȳȤȮȜȥȮȡȩȜȭȮȪȻȵȤȥȠȪȦȯȨȡȩȮȫȡȬȡȠȩȜȳȜȧȪȨȫȬȪȲȡȠȯȬȷȭȝȪȬȜȭȧȺȩȷȬɁɆɊɈɁɉɀɏɁɈɗɁɈȼɎɁɌɄȼɇɗɉɁɊȽɑɊɀɄɈɗɁɀɇɛɍȽɊɌȼɊȽɌȼɃɒɊȾ
1.

ȪɀɉɊɌȼɃɊȾɗɁɋɁɌɓȼɎɆɄɈɁɀɄɒɄɉɍɆɄɅɑȼɇȼɎɃȼɕɄɎɉɗɁɊɓɆɄɄɇɄɀɌɏȿɄɁɋɊɀɑɊɀɛɕɄɁɍɌɁɀɍɎȾȼɄɉɀɄȾɄɀɏȼɇɘɉɊɅɃȼɕɄɎɗɀɇɛɋɌɁɀɊɎȾɌȼɕɁɉɄɛɆɊɉɎȼɆɎȼɍɋȼɎɊȿɁɉȼɈɄɄɇɄɋɊɎɁɉɒɄȼɇɘɉɊɄɉɐɁɆɒɄɊɉɉɗɈɄ
ɈȼɎɁɌɄȼɇȼɈɄɋɁɌɁɉɊɍɄɈɗɈɄɍɊɍɇɚɉɊɅ

2.

ȦɊɇɄɓɁɍɎȾɊ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈŠɋɊɎɌɁȽɊȾȼɉɄɚȾɌȼɓȼ

3.

ȣȼɋɊɇɉɄɎɁɄɉɐɊɌɈȼɒɄɚɀɇɛɄɀɁɉɎɄɐɄɆȼɒɄɄɊȽɌȼɃɒɊȾ ɉȼəɎɄɆɁɎɆɁ 

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ȭȽɊɌɍɇɚɉɗɍɇɁɀɏɁɎɋɌɊȾɊɀɄɎɘɉɁɌȼɉɁɁɓɁɈɓɁɌɁɃɈɄɉɏɎɋɊɍɇɁɓɄɍɎɆɄɃɏȽɊȾɋɌɄɁɈȼɋɄɕɄ ɂɄɀɆɊɅɎȾɁɌɀɊɅ ɄɇɄɋɁɌɊɌȼɇɘɉɊȿɊɋɌɄɁɈȼɇɁɆȼɌɍɎȾȾɊɄɃȽɁɂȼɉɄɁɃȼȿɌɛɃɉɁɉɄɛɍɇɚɉɗ
ɋɊɍɎɊɌɊɉɉɄɈɄȾɁɕɁɍɎȾȼɈɄȣȼɈɄɉɏɎɀɊɍȽɊɌȼɋɌɊȽɗɍɇɁɀɏɁɎɋɌɊɋɊɇɊɍɆȼɎɘɌɊɎȾɊɀɊɅȾɎɁɓɁɉɄɁşɍȩɁɋɊɍɌɁɀɍɎȾɁɉɉɊɋɁɌɁɀɍȽɊɌɊɈɋɌɊȽɗɍɇɁɀɏɁɎȾɗɈɗɎɘɄȾɗɍɏɔɄɎɘɌɏɆɄ
ȤɃȾɇɁɆɄɎɁȼȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɀȾɏɈɛɋȼɇɘɒȼɈɄɃȼɃȼɀɉɄɅɆɊɉɁɒɄɃɊɎɆɌɗɎɊɅɍɄɍɎɁɈɗ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɄ
ɋɊɇɊɂɄɎɁɁȿɊȾɌɊɎɋȼɒɄɁɉɎȼ
ȜȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɀɊɇɂɁɉɉȼɑɊɀɄɎɘɍɛȾɊɌɎɏɋȼɒɄɁɉɎȼ ɉȼɋɌɄɈɁɌȾɃȼɕɁɓɉɊɈɈɁɔɆɁ ȾɎɁɓɁɉɄɁɈɄɉɏɎȫɊɋɌɊɍɄɎɁɋȼɒɄɁɉɎȼɉɁɍɊȾɁɌɔȼɎɘɂɁȾȼɎɁɇɘɉɗɑɀȾɄɂɁɉɄɅȾəɎɊɎɋɁɌɄɊɀ
ȨɄɉɄɈȼɇɘɉɊɁɆɊɇɄɓɁɍɎȾɊɍɊȽɌȼɉɉɊɅɍɇɚɉɗɀɊɇɂɉɊɍɊɍɎȼȾɇɛɎɘɈɆɇȫɌɄɆɌȼɅɉɁɉɁɃɉȼɓɄɎɁɇɘɉɊɈɍɇɚɉɊɊȽɌȼɃɊȾȼɉɄɄȼȽɍɊɌȽɄɌɏɚɕɄɅȾȼɇɄɆɈɊɂɉɊɊɍɎȼȾɄɎɘȾɊɌɎɏɋȼɒɄɁɉɎȼɉȼȽɊɇɁɁ
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ȠɇɛɋȼɒɄɁɉɎȼɀɇɛɍɀȼɓɄɋɌɊȽɗɍɇɚɉɗȾɋɇɊɎɉɊɃȼɆɌɗɎɊɅɍɄɍɎɁɈɁ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɍɊȽɇɚɀȼɅɎɁɏɆȼɃȼɉɄɛȾɌȼɓȼɄɋɊɇɘɃɏɅɎɁɍɘɋɌɁɀɊɍɎȼȾɇɁɉɉɊɅȾɌȼɓɊɈȾɎɊɌɄɓɉɊɅɋɌɊȽɄɌɆɊɅɄɎɌȼɉɍɋɊɌɎɉɊɅ
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ȠɇɛȾɌȼɓȼɄɇȼȽɊɌȼɎɊɌɄɄ
ȤɃɃȼɎɊȿɊɓɎɊɋɌɄɆɊɈɉȼɎɉɊɅɎɁɈɋɁɌȼɎɏɌɁɌɊɍɎȽȼɆɎɁɌɄɅȾɍɇɚɉɁɉȼɓɄɉȼɁɎɍɛɏɂɁɓɁɌɁɃɉɁɍɆɊɇɘɆɊɓȼɍɊȾɌɁɆɊɈɁɉɀɏɁɎɍɛɋɊɍɇɁɍȽɊɌȼɋɌɊȽɗɋɇɊɎɉɊɃȼɆɌɗɎɘɍɄɍɎɁɈɏ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɄ
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ȫɊɍɇɁɒɁɉɎɌɄɐɏȿɄɌɊȾȼɉɄɛɄɃȾɇɁɆɄɎɁɋɊɀȾɁɍɉɏɚɋɌɊȽɄɌɆɏɍɋɌɊȽɆɊɅɄɃɋɇȼɍɎɄɆɊȾɊɅɋɌɊȽɄɌɆɄɍɆɊɉɄɓɁɍɆɄɈɀɉɊɈ
ȞɆɊɉɄɓɁɍɆɊɈɀɉɁɋɇȼɍɎɄɆɊȾɊɅɋɌɊȽɄɌɆɄɉȼɀɊɍȼɀɆɊɈɉȼɑɊɀɛɕɄɈɍɛȾɌɁɃɁɌȾɏȼɌɁɍɊȽɄɌȼɁɎɍɛɓɄɍɎȼɛɍɇɚɉȼɀɇɛɀȼɇɘɉɁɅɔɁȿɊȼɉȼɇɄɃȼ
ȫɊɍɇɁȼɉȼɇɄɃȼɏɎɄɇɄɃɄɌɏɅɎɁɋɇȼɍɎɄɆɊȾɏɚɋɌɊȽɄɌɆɏɍɆɊɉɄɓɁɍɆɄɈɀɉɊɈɄɋɊɀȾɁɍɉɏɚɋɌɊȽɄɌɆɏȾɆɊɉɎɁɅɉɁɌɁɀɇɛɏɎɄɇɄɃȼɒɄɄ

ȯɎɄɇɄɃȼɒɄɛŠɀɇɛȾɌȼɓɁɅɄɇȼȽɊɌȼɎɊɌɄɅ
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ȭɊȽɇɚɀȼɅɎɁɍȼɉɄɎȼɌɉɊȿɄȿɄɁɉɄɓɁɍɆɄɁɋɌȼȾɄɇȼɄɋɌɁɀɋɄɍȼɉɄɛɋɊɉȼɀɇɁɂȼɕɁɅɏɎɄɇɄɃȼɒɄɄɄɉɐɁɆɒɄɊɉɉɗɑɈȼɎɁɌɄȼɇɊȾ

2.

ȠɇɛɍɉɄɂɁɉɄɛɌɄɍɆȼɄɉɐɄɒɄɌɊȾȼɉɄɛɄɍɋɊɇɘɃɏɅɎɁɊɀɉɊɌȼɃɊȾɗɁɋɁɌɓȼɎɆɄ

3.

ȣȼȿɌɛɃɉɁɉɉɗɁɄɇɄɃȼɋɊɇɉɁɉɉɗɁɍɄɍɎɁɈɗ6DOLYHWWH®ɍɆɊɌɎɄɃɊɇɊɈɍɇɁɀɏɁɎɏɎɄɇɄɃɄɌɊȾȼɎɘȾɍɊɊɎȾɁɎɍɎȾɏɚɕɄɑɆɊɉɎɁɅɉɁɌȼɑɀɇɛɏɎɄɇɄɃȼɒɄɄȽɄɊɇɊȿɄɓɁɍɆɄɊɋȼɍɉɗɑɊɎɑɊɀɊȾɍɄɑɋɊɍɇɁɀɏɚɕɁɅ
ɍɎɁɌɄɇɄɃȼɒɄɁɅȾȼȾɎɊɆɇȼȾɁɄɍɂɄȿȼɉɄɁɈ

4.

ȯɎɄɇɄɃȼɒɄɛɀɊɇɂɉȼɊɍɏɕɁɍɎȾɇɛɎɘɍɛȾɍɋɁɒɄȼɇɘɉɊɅɋɁɓɄɀɇɛɍɂɄȿȼɉɄɛɊɎɑɊɀɊȾɄɇɄɍɋɊɈɊɕɘɚȼȾɎɊɆɇȼȾȼ ɍɎɁɌɄɇɄɃȼɒɄɛɋȼɌɊɈ 63

RUȧɄɎɁɌȼɎɏɌȼ
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

ȬȼɍɔɄɐɌɊȾɆȼɍɄɈȾɊɇɊȾɄɊȽɊɃɉȼɓɁɉɄɅ

ȜɌɎɄɆɏɇɘɉɗɅɉɊɈɁɌ

ȪȽɊɃɉȼɓɁɉɄɁɋȼɌɎɄɄ

ȟɊɀɁɉɀɊ

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ȠɄȼȿɉɊɍɎɄɆȼ In vitroȭɊȽɇɚɀȼɅɎɁɄɉɍɎɌɏɆɒɄɚɋɊəɆɍɋɇɏȼɎȼɒɄɄ

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66

SK
Literatúra
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)/HJHQGDV\PERORYDbR]QDÕHQì.DWDOĂJRYÜÕìVOR

Kód dávky

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Diagnostika in-vitro

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67

Navodila za uporabo – Salivette® Cortisol SARSTEDTSL

Namen uporabe
Salivette® Cortisol je epruveta za vzorce sline in jo uporabljamo za odvzem, transport, obdelavo in shranjevanje sline za diagnosticiranje kortizola in-vitro. Izdelek lahko v profesionalnem okolju uporabljajo strokovni
zdravstveni delavci in strokovnjaki v laboratoriju.

Opis izdelka
Epruveta Salivette®&RUWLVROMHVHVWDYOMHQDL]SUR]RUQHSODVWLÕQHSRVRGLFHVNRQLÕDVWLPGQRPYLVHÕHSRVRGLFHYSRMQHJDWDPSRQDLQPRGUHJD]DPDđND51.1534.500=

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posodica+YLVHÕDSRVRGLFD+

vpojni tampon+

moder zamašek

9DUQRVWQDQDYRGLODLQRSR]RULOD
1.

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2.

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in postopke, ki veljajo v vaši ustanovi.

3.

Slina, odvzeta in obdelana z epruveto Salivette®&RUWLVROQLSULPHUQD]DSRQRYQRYUDÕDQMHYÕORYHđNRWHOR

4.

Epruvete Salivette®&RUWLVROSRSUHWHNXGDWXPDXSRUDEQRVWLQHVPHWHYHÕXSRUDEOMDWL8SRUDEQRVWHSUXYHWH6DOLYHWWH®&RUWLVROSRWHÕH]DGQMLGDQQDYHGHQHJDPHVHFDLQOHWD

6KUDQMHYDQMH
Epruveto Salivette® Cortisol hranite pri sobni temperaturi.

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epruveto Salivette® Cortisol v hladilniku.

2PHMLWYH
2GY]HPVOLQHMHWUHEDL]YHVWLQDMPDQMbPLQXWSRREURNX WHNRÕDWUGQDKUDQD ÕLđÕHQMX]REDOLRUDOQHPMHPDQMX]GUDYLOGDSUHSUHÕLPRNRQWDPLQDFLMRVOLQH]PRWHÕLPLVXEVWDQFDPLqDVLQWHPSHUDWXUDVKUDQMHYDQMDVWDRGYLVQDRGXSRUDEQRVWLSDUDPHWURYSUHLVNDYH=DWRLQ]DUDGLSULVREQLWHPSHUDWXULĭHSRQHNDMXUDKVSURĭHQLUDVWLEDNWHULMYVOLQLMHSULSRURÕOMLYRGDHSUXYHWR6DOLYHWWH® Cortisol po
odvzemu vzorca tesno zaprete ali za centrifugiranje ali analiziranje v štirih urah ali za neposredno shranjevanje v hladilniku za nadaljnje postopke.

2GY]HPY]RUFDLQURNRYDQMH
PRED ODVZEMOM SLINE V CELOTI PREBERITE TA DOKUMENT.
Material, potreben za odvzem vzorca:
1.

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2.

Število epruvet Salivette® Cortisol skladno z zahtevami zdravnika.

3.

9SLđLWHSRGDWNH]DLGHQWLıNDFLMRY]RUFD QDHWLNHWL 

68

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vzorca usta 1–5 sekund splakujte z vodo.
Neposredno pred odvzemom sline umijte roke in jih posušite.
Vpojni tampon z zadnjega konca z dvema prstoma vzemite iz odprte epruvete Salivette® Cortisol in
JDSRORĭLWHYXVWD
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Tampon na zadnjem koncu z dvema prstoma vzemite iz ust in
ga vstavite neposredno v epruveto Salivette® Cortisol, ki jo zaprite z belim zamaškom.
Za bolnika:=DYUDÕLORY]RUFDVOLQHYWHVQR]DSUWLHSUXYHWL6DOLYHWWH®&RUWLVROXSRđWHYDMWHQDYRGLOD]GUDYQLNDLQXSRUDELWHVHNXQGDUQRSRVRGRLQđNDWORYUHÕNR]DSRđLOMDQMHNDUSULSUDYL]GUDYQLNqHYUDÕLORQL
neposredno, hranite to epruveto Salivette® Cortisol v hladilniku.
Za zdravnika in laboratorij:]DUDGLĭHSULVREQLWHPSHUDWXULĭHSRQHNDMXUDKVSURĭHQLUDVWLEDNWHULMYVOLQLMHSULSRURÕOMLYRGDHSUXYHWR6DOLYHWWH®&RUWLVROSRRGY]HPXY]RUFDWHVQR]DSUHWHYđWLULKXUDKSULb[bJ]DGYHPLQXWLDOL]Dcentrifugiranje ali analiziranje ali za neposredno shranjevanje v hladilniku za nadaljnje postopke.
3RFHQWULIXJLUDQMXYLVHÕRSRVRGLFR]]DPDđNRPY]HPLWHL]SODVWLÕQHSRVRGLFHVNRQLÕDVWLPGQRP
9NRQLÕDVWHPGQXSODVWLÕQHSRVRGLFHMHÕLVWDVOLQD]DQDGDOMQMRDQDOL]RQDGRVWDQNLNLVRYUH]HUYRDUMXNRQLÕDVWHJDGQD
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1.

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2.

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3.

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4.

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69

SL
Literatura
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

6LPEROLLQR]QDÕHYDOQHNRGHŠtevilka izdelka

Oznaka serije

Uporabno do

Znak CEIn-vitro diagnostika

Upoštevajte navodila za uporabo.

Pri ponovni uporabi: nevarnost kontaminacije+UDQLWH]DđÕLWHQRSUHGVRQÕQRVYHWORER

Hranite na suhem mestu.

Proizvajalec'UĭDYDYNDWHULMHELOL]GHOHNL]GHODQ3ULGUĭXMHPRVLSUDYLFRGRWHKQLÕQLKVSUHPHPEO vseh resnih dogodkih v zvezi s proizvodom je treba obvestiti proizvajalca in pristojni nacionalni organ.

70

Bruksanvisning – SARSTEDT Salivette® CortisolSV$QYËQGQLQJ
Salivette® Cortisol är ett provrör för salivprov som används för provtagning, transport, bearbetning och förvaring av saliv för diagnostiska analyser av kortisol in-vitro. Produkten är avsedd för professionell användning av
medicinskt utbildad personal.

3URGXNWEHVNULYQLQJSalivette® Cortisol består av ett transparent plaströr med konformad botten, ett insatsrör, en svabb och ett blått lock.

51.1534.500=

Plaströr+

Insatsrör

+

Svabb

+

blått lock6ËNHUKHWVDQYLVQLQJDURFKYDUQLQJDU
1.

3URGXNWHQIÎULQWHDQYËQGDVDYEDUQXQGHUÎUHOOHUDYSDWLHQWHUPHGIąUKąMGNYËYQLQJVULVN

2.

Allmänna försiktighetsåtgärder: Använd handskar och annan personlig skyddsutrustning för skydd mot potentiellt smittförande provmaterial. Klinikens säkerhetsriktlinjer och -förfaranden måste följas.

3.

Den med Salivette® Cortisol insamlade och bearbetade saliven är inte avsedd för återinföring i människokroppen.

4.

Använd inte Salivette® Cortisol efter sista förbrukningsdag. Utgångsdatum för en Salivette® Cortisol är den sista dagen i angiven månad och år.

)ąUYDULQJ
Förvara Salivtte® Cortisol vid rumstemperatur före användning.

Transport
Produkten kan transporteras manuellt internt eller i ett sekundärkärl i enlighet med ADR (förpackningsinstruktion P650). För provtransport av Salivette® Cortisol rekommenderas ett sekundärkärl enligt ADR(förpackningsinstruktion P650) art.-nr. 78.898 med absorberande inlägg plus skruvförslutning art.-nr. 65.679 samt en leveranslåda/-påse.
För patienten:
Följ läkarens anvisningar när du returnerar salivprovet i den väl förslutna Salivette® Cortisol och använd sekundärkärlet och leveranslådan/-påsen som läkaren har tillhandahållit. Om provet inte returneras på en gång,förvaras Salivette® Cortisol i kylskåp.

Förbehåll
För att undvika att salivprovet förorenas ska salivuppsamlingen ske tidigast 60 minuter efter intag av föda (flytande/fast), tandborstning eller oralt intag av läkemedel.
Lagringstid och temperatur beror på hållbarheten för de parametrar som ska undersökas. Eftersom det sker en tillväxt av bakterier i saliven efter ett par timmar i rumstemperatur rekommenderas att Salivette® Cortisol
försluts väl efter provtagning och antingen centrifugeras och analyseras inom 4 timmar eller omedelbart placeras i kylskåp för förvaring inför vidare bearbetning.

3URYWDJQLQJRFKKDQWHULQJLÄS DETTA DOKUMENT I SIN HELHET INNAN DU PÅBÖRJAR SALIVUPPSAMLINGEN.
För provtagning nödvändigt arbetsmaterial:
1.

Handskar, skyddsrock, ögonskydd eller andra lämpliga skyddskläder för skydd mot med saliv överförda patogener eller potentiellt infektiösa material.

2.

Antal Salivette® Cortisol enligt läkarens ordination.

3.

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71

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- 30

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Tvätta händerna och torka dem precis innan provuppsamlingen.
Ta ut svabben ur den öppnade Salivette® Cortisol genom att ta i dess bakre ände med två fingrar
Placera sugrullen i munnen.
Svabben ska ligga kvar i 2 minuter i munnen (t.ex. vid kinden) utan tuggrörelser. Mängden saliv som samlas in ska vara minst 500 μl. Vid en väldigt låg salivproduktion, låt rullen ligga kvar längre i munnen.
Ta ut svabben ur munnen genom att ta i dess bakre ände med två fingrar
Placera omedelbart i Salivette® Cortisol och förslut med det blå locket.
För patienten: Följ läkarens anvisningar när du returnerar salivprovet i den väl förslutna Salivette® Cortisol och använd sekundärkärlet och leveranslådan/-påsen som läkaren har tillhandahållit. Om provet inte
returneras på en gång, förvaras Salivette® Cortisol i kylskåp.
För läkare och laboratorium:På grund av den bakterietillväxt i saliven som kan förekomma efter ett par timmar i rumstemperatur rekommenderas att Salivette® Cordisol försluts väl efter provtagning och antingen centrifugeras i 2 minuter vid
b[JRFKDQDO\VHUDVLQRPWLPPDUHOOHURPHGHOEDUWSODFHUDVLN\OVNÎSIąUIąUYDULQJLQIąUYLGDUHEHDUEHWQLQJ
Efter centrifugeringen ska insatsröret inklusive locket tas ut ur plaströret med konformad botten.
I plastkärlets konformade botten samlas den rena saliven för vidare analys ovanför bottensatsen som samlas i kärlets reservoar.
Efter avslutad analys ska plaströret med konisk botten samt insatsröret kasseras i en avfallsbehållare.

$YIDOOVKDQWHULQJşJËOOHUIąUOËNDUHRFKODERUDWRULXP
1.

Ta hänsyn till och följ allmänna hygieniska riktlinjer och lagbestämmelser gällande korrekt avfallshantering av smittförande material.

2.

Engångshandskar minskar risken för infektion.

3.

Kontaminerade eller fyllda Salivette® Cortisol måste placeras i lämpliga avfallsbehållare för biologiskt riskavfall, som direkt kan autoklaveras och brännas.

4.

Avfallshanteringen måste ske i för ändamålet lämplig förbränningsanläggning eller genom autoklavering (ångsterilisering).

72

SV
Litteratur
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

Förklaring av symboler och märkning:

Artikelnummer

Satsbeteckning

Användbar till och med

CE-märkning

In-vitro-diagnostik

Följ bruksanvisningen

Vid återanvändning: Risk för kontaminering

Förvaras skyddad mot solljus

Förvaras torrt

Tillverkare

Tillverkningsland

Med reservation för tekniska ändringar.
Alla allvarliga händelser i samband med produkten ska rapporteras till tillverkaren och den behöriga nationella myndigheten.

73คําแนะนําในการใช้งาน – หลอดเก็บน้ําลาย Salivette® คอร์ติซอล ของ SARSTEDT

THวัตถุประสงค์ในการใช้งาน
หลอดเก็บน้ําลาย Salivette® คอร์ติซอล เป็นหลอดเก็บตัวอย่างน้ําลายและใช้สําหรับการเก็บรวบรวม การขนส่ง การดําเนินการ และการเก็บรักษาตัวอย่างน้ําลายสําหรับการวิเคราะห์หาปริมาณฮอร์โมนคอร์ติซอลในหลอดทดลอง ผลิตภัณฑ์มีไว้สําหรับการใช้งานในสถานพยาบาลโดยเฉพาะและต้องใช้งานโดย
บุคลากรที่ได้รับการฝึกอบรมทางการแพทย์มาแล้วและบุคลากรในห้องปฏิบัติการเท่านั้น

คําอธิบายผลิตภัณฑ์
หลอดเก็บน้ําลาย Salivette® คอร์ติซอล ประกอบด้วยหลอดพลาสติกใสที่มีก้นแหลม หลอดแขวนลอย ม้วนดูดน้ําลาย และฝาปิดสีน้ําเงิน

51.1534.500=

หลอดพลาสติก

+หลอดแขวนลอย

+ม้วนดูดน้ําลาย

+ฝาปิดสีน้ําเงิน

ข้อแนะนําด้านความปลอดภัยและคําเตือน
1.

ห้ามใช้ผลิตภัณฑ์นี้กับเด็กอายุต่ํากว่า 3 ปีและผู้ป่วยที่มีความเสี่ยงต่อการสําลัก

2.

ข้อควรระวังทั่วไป: สวมถุงมือและอุปกรณ์ป้องกันส่วนบุคคลทั่วไปอื่นๆ เพื่อป้องกันการสัมผัสกับเชื้อโรคที่แพร่กระจายทางวัสดุตัวอย่างที่อาจติดเชื้อ ต้องปฏิบัติตามระเบียบข้อบังคับและขั้นตอนด้านความปลอดภัยในสถานพยาบาลเสมอ

3.

ห้ามนําน้ําลายที่เก็บและจัดเตรียมด้วยหลอดเก็บน้ําลาย Salivette® คอร์ติซอล กลับเข้าไปในร่างกายมนุษย์อีกครั้ง

4.

ห้ามใช้หลอดเก็บน้ําลาย Salivette® คอร์ติซอล หลังจากวันหมดอายุ หลอดเก็บน้ําลาย Salivette® คอร์ติซอล ใช้งานได้ถึงวันสุดท้ายของเดือนและปีที่ระบุ

การเก็บรักษา
เก็บหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ไว้ที่อุณหภูมิห้องก่อนการใช้งาน

การขนส่ง
ผลิตภัณฑ์นี้สามารถขนส่งภายในสถานพยาบาลด้วยมือหรือขนส่งโดยใช้หลอดเก็บตัวอย่างอีกหลอดหนึ่งที่ได้มาตรฐาน ADR (คําแนะนําในการบรรจุภัณฑ์ P650) การขนส่งตัวอย่างในหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ต้องเป็นไปตามมาตรฐาน ADR (คําแนะนําในการบรรจุภัณฑ์ P650) ขอแนะนําให้ใช้
หลอดสําหรับขนส่ง รหัสสินค้า 78.898 ร่วมกับแผ่นดูดซับและฝาเกลียว รหัสสินค้า 65.679 และกล่อง/ถุงสําหรับขนส่ง
สําหรับผู้ป่วย:การส่งคืนตัวอย่างน้ําลายในหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ที่ปิดฝาแน่นดีแล้ว ให้ปฏิบัติตามคําแนะนําของแพทย์และใช้หลอดเก็บตัวอย่างอีกหลอดหนึ่งและกล่อง/ถุงสําหรับขนส่งที่แพทย์ให้มาด้วย หากไม่สามารถส่งคืนตัวอย่างได้โดยตรงทันที ให้เก็บหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ไว้ในตู้เย็น

ข้อจํากัด
ควรเก็บตัวอย่างน้ําลายหลังจากการรับประทานอาหาร (ทั้งที่เป็นของเหลว/ของแข็ง) การแปรงฟัน หรือการทานยาผ่านไปแล้วอย่างน้อย 60 นาที เพื่อหลีกเลี่ยงการปนเปื้อนของสารอื่นๆ ที่รบกวนคุณสมบัติของน้ําลาย
ระยะเวลาและอุณหภูมิในการจัดเก็บขึ้นอยู่กับอายุการใช้งานของตัวแปรที่จะตรวจวิเคราะห์ ด้วยเหตุผลนี้ และเนื่องจากการเจริญเติบโตของแบคทีเรียในน้ําลายจะเริ่มขึ้นหลังจากผ่านไปไม่กี่ชั่วโมงที่อุณหภูมิห้อง ขอแนะนําให้ปิดฝาหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ให้แน่นหลังจากการเก็บตัวอย่าง แล้วนํา
ไปหมุนเหวี่ยงและตรวจวิเคราะห์ภายใน 4 ชั่วโมง หรือนําไปเก็บไว้ในตู้เย็นทันทีจนกว่าจะนํามาตรวจวิเคราะห์ต่อไป

การเก็บตัวอย่างและการจัดการ
กรุณาอ่านและทําความเข้าใจเอกสารนี้อย่างละเอียดก่อนเริ่มทําการเก็บตัวอย่างน้ําลาย
สําหรับการเก็บตัวอย่างต้องมีวัสดุใช้งานที่จําเป็น:1.

สวมใส่ถุงมือ ผ้ากันเปื้อน อุปกรณ์ปกป้องดวงตา หรือชุดป้องกันอื่นๆ ที่เหมาะสมสําหรับการป้องกันเชื้อโรคที่แพร่กระจายทางน้ําลายหรือวัสดุที่อาจมีการติดเชื้อ

2.

หลอดเก็บน้ําลาย Salivette® คอร์ติซอล ตามจํานวนที่แพทย์สั่ง

3.

ข้อมูลสําหรับการระบุตัวอย่าง (บนสติกเกอร์)74

THการเก็บตัวอย่าง
- 60 นาที

- 50

- 40

- 30

- 20

- 10 นาที

0

2 นาทีโดยไม่ต้องเคี้ยว
1-5 วินาที

HƴO

2 นาที
1,000 x gตัวอย่าง

ตะกอนควรเก็บตัวอย่างน้ําลายหลังจากการรับประทานอาหาร (ทั้งที่เป็นของเหลว/ของแข็ง) การแปรงฟัน หรือการทานยาผ่านไปแล้วอย่างน้อย 60 นาที เพื่อหลีกเลี่ยงการปนเปื้อนของสารอื่นๆ ที่รบกวนคุณสมบัติของน้ําลาย ก่อนการเก็บตัวอย่างไม่เกิน 10 นาที ให้บ้วนล้างปากให้สะอาดด้วยน้ําเป็นเวลา 1-5วินาที
ล้างมือและเช็ดให้แห้ง จากนั้นให้ทําการเก็บตัวอย่างน้ําลายทันที
ใช้นิ้วมือสองนิ้วหยิบปลายด้านหลังของม้วนดูดน้ําลายออกจากหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ที่เปิดแล้ว และเอาใส่เข้าไปในปาก
อมม้วนดูดน้ําลายไว้ในปาก (เช่น บริเวณกระพุ้งแก้ม) นาน 2 นาทีโดยไม่ต้องเคี้ยว ปริมาณขั้นต่ําของน้ําลายที่ต้องเก็บควรเป็น 500 ไมโครลิตร หากมีน้ําลายน้อยมาก ให้อมม้วนดูดน้ําลายไว้ในปากนานกว่านั้น
ใช้นิ้วมือสองนิ้วหยิบปลายด้านหลังของม้วนดูดน้ําลายออกจากปาก และเสียบเข้าไปในหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ทันทีแล้วปิดด้วยฝาสีน้ําเงินให้แน่น
สําหรับผู้ป่วย: การส่งคืนตัวอย่างน้ําลายในหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ที่ปิดฝาแน่นดีแล้ว ให้ปฏิบัติตามคําแนะนําของแพทย์และใช้หลอดเก็บตัวอย่างอีกหลอดหนึ่งและกล่อง/ถุงสําหรับขนส่งที่แพทย์ให้มาด้วย หากไม่สามารถส่งคืนตัวอย่างได้โดยตรงทันที ให้เก็บหลอดเก็บน้ําลาย Salivette®
คอร์ติซอล ไว้ในตู้เย็น
สําหรับแพทย์และห้องปฏิบัติการ:เนื่องจากการเจริญเติบโตของแบคทีเรียในน้ําลายจะเริ่มขึ้นหลังจากผ่านไปไม่กี่ชั่วโมงที่อุณหภูมิห้อง ขอแนะนําให้ปิดฝาหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ให้แน่นหลังจากการเก็บตัวอย่าง แล้วนําไปหมุนเหวี่ยงด้วยแรง 1,000 x g นาน 2 นาทีและตรวจวิเคราะห์ภายใน 4 ชั่วโมง หรือนําไปเก็บไว้ใน
ตู้เย็นทันทีจนกว่าจะนํามาตรวจวิเคราะห์ต่อไป
หลังจากการหมุนเหวี่ยง ให้นําหลอดแขวนลอยพร้อมทั้งฝาปิดออกจากหลอดพลาสติกที่มีก้นแหลม
น้ําลายบริสุทธิ์สําหรับการตรวจวิเคราะห์ต่อไปจะลอยอยู่เหนือเศษตะกอนที่สะสมอยู่ในก้นแหลมของหลอดพลาสติก
หลังจากการตรวจวิเคราะห์ ให้ทิ้งหลอดพลาสติกที่มีก้นแหลมและหลอดแขวนลอยลงในภาชนะสําหรับทิ้ง

การทิ้ง – ใช้สําหรับแพทย์และห้องปฏิบัติการ
1.

ต้องศึกษาและปฏิบัติตามแนวทางปฏิบัติดา้ นสุขอนามัยทั่วไปและข้อกําหนดของกฎหมายสําหรับการทิ้งวัสดุติดเชื้ออย่างถูกต้อง

2.

การสวมถุงมือแบบใช้ครั้งเดียวจะช่วยป้องกันความเสี่ยงในการติดเชื้อ

3.

ต้องทิ้งหลอดเก็บน้ําลาย Salivette® คอร์ติซอล ที่มีการปนเปื้อนหรือใส่น้ําลายแล้วลงในภาชนะสําหรับทิ้งสารชีวภาพอันตรายที่เหมาะสมซึ่งสามารถนําไปอบฆ่าเชื้อและเผาทําลายในภายหลังได้

4.

ต้องทิ้งโดยใช้เตาเผาหรือใช้การอบฆ่าเชื้อ (การนึ่งฆ่าเชื้อ) ที่เหมาะสม

75

THเอกสารอ้างอิง
เอกสารข้อมูลของ SARSTEDT https://www.sarstedt.com/en/products/diagnostic/salivasputum/ บทความเรื่อง "Comparing cortisol levels of saliva samples collected with the passive drool collection method with the ® Cortisol" (การเปรียบเทียบระดับฮอร์โมนคอร์ติซอลในตัวอย่างน้ําลายที่เก็บด้วย
วิธีปล่อยให้น้ําลายไหลเองโดยใช้หลอดเก็บน้ําลาย Salivette® คอร์ติซอล)Kirschbaum, Hellhammer “Salivary Cortisol” (คอร์ติซอลในน้ําลาย), Encyclopedia of STRESS (สารานุกรมแห่งความเครียด) ฉบับแก้ไขครั้งที่ 1, เล่มที่ 3:379-383, 2000 (อ้างอิงในฉบับแก้ไขครั้งที่ 2 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

สัญลักษณ์และรหัสระบุ:รหัสสินค้า

หมายเลขรุ่นที่ผลิต

ใช้ได้จนถึง

สัญลักษณ์ CEการตรวจวินิจฉัยในหลอดทดลอง

กรุณาดูคําแนะนําในการใช้งาน

ในกรณีการนํากลับมาใช้ซ้ํา: อันตรายจากการปนเปื้อน

เก็บให้พ้นแสงแดด

เก็บไว้ในที่แห้ง

ผู้ผลิต

ประเทศที่ผลิต

สงวนสิทธิ์ในการดัดแปลงทางเทคนิค
หากพบอุบัติการณ์ร้ายแรงใดๆ ที่เกี่ยวข้องกับผลิตภัณฑ์ จะต้องแจ้งให้ผู้ผลิตและผู้มีหน้าที่กํากับดูแลผลิตภัณฑ์ในประเทศของท่านทราบ

76

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Doktor ve Laboratuvar için:
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Literatür
SARSTEDT Whitepaper https://www.sarstedt.com/en/products/diagnostic/salivasputum/ Literature / „Comparing cortisol levels of saliva samples collected with the passive drool collection methodwith the Salivette® Cortisol“
Kirschbaum, Hellhammer “Salivary Cortisol”, Encyclopedia of STRESS 1st ed, vol 3:379-383, 2000 (cited in 2nd ed. 405-409 2007; doi.org/10.1016/B978-012373947-6.00334-2)

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