Merit Medical Exacta Mode D'emploi

Monitoring Life™
Instructions for use
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Instructie voor
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Mode d'emploi
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Οδηγίες χρήσης
Istruzioni per l'uso
Instruções de Uso
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применению
Instrucciones de
uso
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användning
Exacta™
Percutaneous Sheath Introducer
The following are general instructions for use of the Exacta™
Percutaneous Sheath Introducer kit. Clinicians are strongly
recommended to follow this procedure, or an alternative with
which they are familiar, or which conforms to their hospital
standard practice.
Description
The Merit Exacta Percutaneous Sheath Introducer is a semi-
rigid introducer through which
catheter and central venous catheter can be introduced
percutaneously. The introducer is supplied in a kit that
includes a scalpel, guidewire, over-needle introducer, and
needle introducer, syringe, contamination shield, and Dilator/
IObturator.
Intended Use
Merit
Exacta Percutaneous Sheath
surgically invasive devices that
short term use (no longer than 30 days) to allow
introduction of balloon-tipped catheters into the human
central circulatory system. This
access allows direct measurement
within the chambers of heart,
thermodilution cardiac measurements,
drugs & fluids and transvenous pacing.
All cautions should be read and understood before
attempting to use this kit.
CAUTION Use only as directed by a physician. A full list of
components is on the package lid.
General Warnings
1. Complications associated with percutaneous sheath intro
duction include vessel wall perforation, pleural and mediastinal
injury, air embolism, catheter embolism, thoracic duct
laceration, bacteraemia, septicaemia, thrombosis, and
inadvertent arterial puncture.
2. The patient should be placed in a slight Trendelenburg
position for subclavian or jugular introduction.
3. Luer connections: as standard practice, the security of
luer connections must be checked routinely.
4. When removing dressings at or close to catheter sites,
care must be taken to avoid severing the catheter.
5. Acetone must not come in contact with the catheter as the
material may weaken and this may result in leakage or
aspiration.
6. Exposure of product componentry to topicals containing
alcohol is not recommended.
7. Do not attempt to re-insert a partially or completely
withdrawn introducer cannula.
8. Percutaneous puncture of a central vein may be
contraindicated in patients with pulmonary hypertension.
9. Use of a syringe smaller than 5 mL to irrigate or de-clot an
occluded catheter may cause catheter rupture.
10. Syringes are supplied for blood aspiration only. Warnings
- Seldinger Technique
1. Do not reinsert the needle into catheter.
2. Maintain a firm grip on the guidewire at all times. Do not
force the guidewire. If resistance is met, carefully withdraw
the guidewire and re-attempt insertion.
3. On withdrawing the guidewire, when using the 18 gauge
thin-wall needle, caution should be taken to prevent damage
or possible severing of the wire on the needle bevel.
4. Potential for guidewire breakage. Although the incidence
of guidewire breakage is extremely uncommon, physicians
must be aware of the potential of guidewire breakage if undue
force is applied to the wire. If resistance is met when
attempting to remove the guidewire after Sheath placement,
the wire may be kinked within the area of the sheath tip and
the vessel. Undue force may cause the wire to break. If
resistance is encountered, withdraw the sheath relative to the
guidewire (2-3 cm) and attempt to remove the wire. If
resistance is still apparent remove the wire and sheath
simultaneously.
Инструкции за
5. Physicians should be aware that the guidewire can pick
употреба
up material from the vein. This may prevent the guidewire
from being withdrawn through the needle.
Upute za upotrebu
Warnings - Sheath Insertion
1. Tuohy Borst adaptor: when using the Tuohy Borst adaptor
Návod k použití
with the Exacta™ Percutaneous Sheath Introducer kit,
caution should be taken not to insert introducer needles into
Használati útmutató
the haemostasis valve.
2. The Contamination Shield is not intended for use as a
Bruksanvisning sterile barrier.
3. Do not insert introducer needles or hypodermic needles
Instrukcja
through the contamination shield.
użytkowania
4. Care should be taken when handling the assembly and
when disconnecting the sideport from an infusion tube, to
Instrucţiuni pentru
prevent air passing into the patient.
utilizare
5. If use of a Merit Percutaneous Sheath Introducer
delayed
Návod na použitie
relevant sized Merit obturator is used with the sideport
assembly and sheath.
Kullanma Talimatı
5 Fr Obturator for 6 Fr & 7 Fr Sheath Introducers.
Kasutamisjuhend
7 Fr Obturator for 8 Fr, 8.5 Fr & 9 Fr Sheath Introducers.
This will maintain sheath patency, ensure against leakage
Naudojimo
and prevent contamination.
instrukcija
6. Ensure that the valve mechanism and contamination
shield are not damaged by sharp objects.
使用說明
7. Hospital Protocols should adhere to the following
instructions for use of stopcock. Excessive force when
connecting, particularly in the presence of lubricious infusates
such as fat emulsions, can cause over stressing to stopcock
ports. Contact with some organic solvents and infusion
solutions can also relieve internal stresses causing the
material to crack. To prevent potential cracks causing air
embolism or other risks to the patient follow four main
principles:
1. Avoid over tightening connections.
2. Check connections regularly.
3. Change stopcocks every 72 hours.
4. When lubricious infusates are used change stopcocks
every 24 hours.
Venaguide™
a balloon-tipped
1. Release guidewire by removing the guidewire cap.
2. Straighten guidewire 'J' by retracting into introducer
system with thumb.
3. Insert into hub of introducer needle and advance
guidewire into vein. Advance to required depth.
WARNING - to prevent over insertion stop when last depth
mark reaches the venepuncture site.
Introducers are
are intended for
venous system
of pressures
blood sampling,
infusion of
Patient Preparation
1. Disinfect, and drape as required, the proposed puncture
site.
2. Perform a skin wheal with local anaesthetic at the
proposed site.
3. Insert the tip of a Criticath™ or other pulmonary artery
catheter
contamination shield. Advance the catheter through tubing
and hub at distal end. Slide contamination shield past the 50
cm mark on the catheter. Extend full length of the sheath and
tighten Tuohy-Borst adaptor at proximal end of sheath.
Sheath Insertion
4. Using the introducer needle (or over needle cannula)
puncture the vein, aspirate and advance the needle (or
cannula) into the vein. Failure to aspirate venous blood
through the needle may indicate incorrect venous puncture.
5. Insert the desired end of the guidewire through the
Introducer. (The 'J' end can be prepared by sliding the plastic
insertion sleeve over the tip to straighten it.)
6. While holding the guidewire in place, remove the
Introducer.
7. If required, enlarge the insertion site with the scalpel.
CARE SHOULD BE TAKEN NOT TO CUT THE GUIDEWIRE.
8. Thread the tip of the dilator over the guidewire until the
guidewire exits the hub of sheath/dilator assembly. While
firmly holding the guidewire in place, grasp dilator near the
skin and advance the sheath/dilator assembly into vessel with
a slight twisting motion.
9. Holding the sheath in place, withdraw the guidewire and
dilator sufficiently to allow venous blood flow to be aspirated
into the side port. Connect to an appropriate intravenous
infusion line and flush.
10. Always remove the dilator over the guidewire after
dilation of the skin.
11. Holding the sheath in place, remove the guidewire and
dilator.
12. Test the catheter balloon according to manufacturer's
recommended procedure and insert tip of catheter into the
Tuohy-Borst adaptor on sheath/sideport assembly.
1/20
or interrupted, it is recommended that the
into the Tuohy-Borst adaptor end
13. Advance the catheter to the desired position. Secure
catheter in place by tightening Tuohy-Borst adaptor on the
sideport assembly. Use of the Tuohy-Borst adaptor may help
prevent catheter migration. CARE SHOULD BE TAKEN TO
AVOID OVER-TIGHTENING
ADAPTOR, as this may occlude the catheter lumen.
14. Suture the sheath in place utilizing suture loop and
recessed ring if desired. If the sheath assembly is not to be
used immediately, an obturator may be used to help preserve
patency.
Physicians should be aware that central venous catheters are
intended for use for up to 30 days.
Storage Conditions
Store in cool dry place away from direct sunlight.
STERILE and non-pyrogenic in unopened, undamaged
package. For single use only. Check integrity of the individual
package before use. Dispose of product after use. Do not
resterilize.
Re-use may lead to infection or other illness/ injury.
This product contains a phthalate which may cause a risk to
{children (male), pregnant or nursing women} in conjunction
with prolonged duration of use.
For reordering information or assistance please contact local
is
representative.
Exacta™
Percutaneous Sheath Introducer
I det følgende gives en generel oversigt over brugen af
Exacta™ percutan sheath introducersæt.
Lægen bør følge denne procedure eller en alternativ, som de
er bekendt med, som er i overensstemmelse med hospitalets
standard praksis.
Beskrivelse
Merit Exacta perkutan hylsterstilette er en halvstiv stilette,
gennem hvilken et
centralt venekateter kan indføres perkutant. Stiletten leveres i
et sæt, som omfatter
overnål og
kontaminationsafskærmning
Tilsigtet brug
Merit Exacta perkutan hylsterstilette er en kirurgisk invasiv
enhed, som er beregnet
længere end 30 dage) for at muliggøre indførelse af
katetere med ballonspids i det menneskelige centrale
kredsløb. Dette veneadgangssystem muliggør direkte
måling af tryk inden i hjertekamrene,
hjertemålinger med
lægemidler og væsker og transvenøs pacing.
Alle advarsler skal være læst og forstået, inden sættet
tages i brug.
Forsigtig Må kun bruges i henhold til lægens anvisning. Der
er en komplet liste over komponenterne på emballagens låg.
Generelle advarsler
1. De komplikationer, der er forbundet med introducersættet,
omfatter karvægsperforation, pleural og mediastinal skade,
luftemboli, kateteremboli, beskadigelse af ductus thoracicus,
bakteriæmi, septicaemi, trombose og arterieperforation.
2. Patienten anbringes i en let Trendelenburg med halsen
vendt bort fra injektionsstedet ved subclaviculær eller v.
jugularis indgang.
3. Luer konnekteringer: det er standard praksis at kontrollere
Luer konnekteringer rutinemæssigt.
4. Ved fjernelse af forbinding på eller i nærheden af
injektionsstedet, skal der udvises forsigtighed for at undgå at
kateteret skæres over.
5. Acetone må ikke komme i kontakt med katetret, da den
of the
kan opløse katetervæggen og resultere i lækage eller
aspiration.
6. Det anbefales, at produktkomponenterne ikke udsættes
for stoffer, der indeholder alkohol.
7. En introducerkanyle, der er helt eller delvis trukket ud, må
aldrig genindføres.
8. Percutan perforering af central vene er kontraindiceret for
patienter med pulmonal hypertension.
9. Brug af sprøjte, der er mindre end 5 mL, til at skylle eller
afblokere et tilstoppet kateter kan forårsage brud på katetret.
10. Sprøjter leveres kun til blodprøve aspiration.
Advarsler - Seldinger teknik
1. Genindfør ikke nålen i kateteret.
2. Hold godt fast på guidewiren hele tiden. Forcer ikke
guidewiren. Hvis der er modstand, skal guidewiren forsigtigt
trækkes ud, og der startes igen.
3. Når der bruges en gauge 18 tyndvægget nål, skal
guidewiren trækkes forsigtigt ud, så nålens skråkant ikke
beskadiger eller skærer wiren over.
4. Risiko for brud på guidewiren Selvom det er meget
sjældent, at der forekommer brud på guidewiren, skal lægen
være opmærksom på risikoen for brud på guidewiren, hvis
den håndteres ukorrekt. Hvis der er modstand, når man
prøver at fjerne guidewiren efter sheath placeringen, kan det
skyldes, at wiren kinker i sheathspids og kar. Pas på at wiren
ikke knækker. Hvis der er modstand, skal sheath trækkes ud
sammen med guidewiren (2-3 cm), og man skal prøve at
fjerne wiren. Hvis der stadig er modstand, skal wire og sheath
fjernes samtidig.
5. Lægen skal være opmærksom på at guidewiren kan
opsamle stoffer fra venen. Dette kan bevirke, at guidewiren
ikke kan trækkes tilbage gennem nålen.
OF THE TUOHY-BORST
kateter med ballonspids og et
skalpel, ledetråd, stilette med
nålestilette, kanyle,
og dilatator/obturator.
til kortvarig brug (ikke
blodprøvetagning,
termoopløsning, infusion af