INSTRUCTIONS FOR USE

Accura Introducer set

Introducer set

Caution
This procedure should be used by physicians with adequate training in the use of the Procedure and device.

Device description
The introducer set contains disposable components used to gainvessel access through a introducer needle.
Each introducer set contains the followings:
■■ Standard introducer sheath
■■ Guide wire
■■ Syringe
■■ Introducer needle
■■ Scalpel
■■ Dilator

Indications
The introducer set is indicated for percutaneous introduction of guidewire or catheter into the vascular system through
introducer needle. The introducer set should be used only by physicians trained in percutaneous, intravascular
techniques and procedures.

Contraindications
Use of introducer set is contraindicated if the patient has a known or suspected obstruction in the subclavian vein.
There is increased risk of pneumothorax for the patient who has severe chronic lung disease. Poor healing may
result in the patient who has had irradiation to the anterior chest.

Warnings
Do not use alcohol, acetone or solutions containing these agents.
These solutions may affect the properties of the plastic components resulting in degradation of the device.
Do not reuse this device.
Do not withdraw guide wires through introducer needles; guide wires may shear or unravel. Do not alter this device

Complications
As with all medical procedures, complications may occur. For this procedure, these may include:
■■ Air embolism
■■ Wound infection
■■ Intimal tear
■■ Subclavian artery puncture
■■ Pneumothorax
■■ Subclavian vein thrombosis
■■ Bleeding
■■ Cardiac arrhythmia
■■ Hematoma formation
■■ Hemothorax
■■ Hydrothorax
■■ Thoracic duct injury
■■ Vessel erosion

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Precautions
The procedure should be performed by physicians thoroughly trained in percutaneous access.
Do not use the introducer set if the packaging has been damaged.
Never advance or withdraw device against resistance until the cause is determined by fluoroscopy or ultrasound
imaging.
Movement of the device against resistance may result in damage to the device or vessel
perforation.
Do not use a  guide wire larger than the maximum diameter specified on the package label. Individual patient
anatomy and physician technique may require procedural variations. Insertion into artery may cause excessive
bleeding and/or other complications.

Clinical procedure
The following instructions provide technical direction but do not obviate the necessity of formal training for gaining
percutaneous access. The techniques and procedures described do not represent ALL medically acceptable
protocols, nor are they intended as a substitute for the physician’s experience and judgment in treating any specific
patient.

Indication for use

Preparations for Use
1. Open package using sterile technique and place contents onto sterile filed.
2. Prepare the skin and drape the area of the anticipated puncture.

Deployment Procedure
1. Insert the introducer needle into the vein or artery and verify position by observing blood return. Adjust
the angle of the needle to accomodate the patient’s build: shallow angle in a thin person, deeper angle in
a heavyset person.
2. Aspirate the introducer needle using a syringe.
3. Remove syringe and insert soft, floppy tip of the guide wire through the introducer needle and into the
vessel. Advance guide wire to required depth while leaving enough of the guide wire outside the body.

WARNING: Do not advance or withdraw the guide wire against resistance. Determine the cause of
resistance before proceeding.

4. While holding the guide wire in place, solwly emove the needle by threading back over the guide wire.

WARNING: Do not withdraw the guide wire into the cannula of the needle, as this may result in separation
of the guide wire. If the guide wire must be withdrawn while threaded through the introducer needle,
remove both the introducer needle and guide wire as a unit to prevent from damaging or shearing the
guide wire.

5. Thread the dilator or introducer sheath over the guide wire

6. Advance the dilator set or introducer sheath using a twisting motion over the guide wire and into the vessl.
Use fluoroscopy or ultrasound to confirm position.
7. Remove the inner dilator and guide wire together.

Packaging & storage

The introducer set has been sterilized with ethylene oxide.
Store in a cool, dry place.

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Product variants

Catalo No. Sheath length Sheath size

3004011 11cm sheath 4F
3005011 11cm sheath 5F
3006011 11cm sheath 6F
3007011 11cm sheath 7F
3008011 11cm sheath 8F
3008511 11cm sheath 8,5F
3009011 11cm sheath 9F
3010011 11cm sheath 10F
3004023 23cm sheath 4F
3005023 23cm sheath 5F
3006023 23cm sheath 6F
3007023 23cm sheath 7F
3008023 23cm sheath 8F
3008523 23cm sheath 8,5F
3009023 23cm sheath 9F
3010023 23cm sheath 10F

Graphic Symbols Contained Indevice Labeling

Sterilized Lot number Do not useif

using Batch package Do not
ethylene number is damaged re-use
oxide

Use-by date Keep dry Keep away Consult

from sunlight instructions
for use

0297
Caution, attend
accompanying Catalogue CE mark
documents Number

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Manufacturer
Accura Medizintechnik GmbH
Max­‑Planck­‑Straße 33
611 84 Karben
Germany

Distributor
CZ Pharma, s. r. o.
Náměstí Smiřických 42
281 63 Kostelec nad Černými Lesy
Czech Republic

Status: 3. 2. 2012