Warning Notice - Straub Medical Aspirex S 6F 110cm Mode D'emploi

Straub Medical AG
®
Aspirex S Catheter
• implants such as stents / stent grafts / bypass grafts getting
damaged, caught or dislodged
• bypass graft damage or rupture
• disruption of the catheter: debris remaining in the body
• allergic reactions to catheter material
• death

Warning notice:

WARNING: Before using a product, the user must verify that the recommended maintenance interval shown on the maintenance label
visible on the Straub Medical Drive System, as recommended in the user manual, is valid.
WARNING: Before using the product, the user must verify that the measures to ensure electromagnetic safety, as recommended in the user
manual, are followed.
WARNING: The Straub Mechanical Thrombectomy System and its components must not be used if magnetic resonance imaging (MRI) is
being employed for imaging purposes: the products contain magnetizable material.
WARNING: The Straub Mechanical Thrombectomy System and its components must not be used if a defibrillator is being used on the
patient: the products are electrically conductive. Remove catheter and guidewire from patient before using a defibrillator.
WARNING: The Straub Mechanical Thrombectomy System and its components must not be used if electrosurgery is being used on the
patient: the products are electrically conductive. Remove catheter and guidewire from patient before using electrosurgery.
WARNING: Straub Medical catheters are delivered sterile. The sterilization method is gasification with ethylene oxide. Further details are
shown on the relevant product labels.
WARNING: The products are for single use and must not be resterilized.
WARNING: Reprocessing or resterilising may severely impair the function of the product, which can cause injury, illness or death of the
patient.
WARNING: Products contaminated with blood may not be reused or resterilized. If the product is contaminated, there is a high risk of
cross-infection between patients.
WARNING: Do not use the products if their sterile blister packaging barriers have been compromised or damaged.
WARNING: Do not use the products after the expiration date.
Precautions:
CAUTION: The catheter sets do not contain any parts that need to be maintained or serviced by the end-user. Do not repair or change the
configuration of the product. An annual service is recommended for the Straub Medical Drive System (see Straub Medical Drive System
user manual).
Instructions for use:
CAUTION: Straub Medical Drive Systems are required to operate Aspirex
CAUTION: Maintain sterile conditions when handling sterile products. Sterile products are labelled with suitable symbols on the package
labelling.
Preparation for use:
1. For set-up and handling of the Straub Medical Drive System (REF SRS Set) consult the user manual of the Straub Medical Drive System. This
provides instructions for handling the sterile drapes included in the catheter set, which are used to cover parts of the Straub Medical Drive
System.
CAUTION: The user must be entirely familiar with the operating instructions of the Straub Medical Drive System and Straub rotational
catheters before using the Straub Mechanical Thrombectomy System and its components.
2. Introduce the appropriate introducer sheath selected into a blood vessel by a suitable method. Perform an angiogram to determine the
patient's initial status. If the initial status is medically and technically suitable, ensure there is sufficient anticoagulation with the appropriate
medication.
CAUTION: Provide sufficient and effective antithrombotic medication before and during the procedure. This is required to prevent vessel
and/or catheter thrombosis during mechanical thrombectomy. Effective anticoagulants at a suitable dose have to be administered before the
patient is treated with the Straub Mechanical Thrombectomy System in order to achieve an activated clotting time (ACT) > 250 seconds or
equivalent values according to other measuring techniques, throughout use of the catheter. Unfractionated heparin in doses sufficient to
achieve ACT > 250 seconds is reported to be safe and effective during percutaneous transluminal catheter interventions [1]. The use of
unfractionated heparin in combination with a suitable platelet aggregation inhibitor as standard medication is recommended at the beginning
of and during mechanical thrombectomy procedures. Low-molecular-weight heparin and/or other anticoagulants might not always prevent
vessel and/or catheter thrombosis despite an ACT > 250 seconds [2],[3] and cannot be antagonized immediately, should the need arise. If
the patient has been pre-treated with anticoagulants other than unfractionated heparin, consider an additional bolus of 15 to 40 IU/kg BW of
unfractionated heparin.
WARNING: Pay particular attention to the patient's entire anticoagulation and platelet aggregation inhibition medication. Anticoagulants
alone or in combination with other drugs can cause an increased and sometimes uncontrollable risk of severe bleeding. Appropriate testing
of the patient's coagulation status is mandatory. All therapeutic options to control bleeding and/or to restore normal coagulation should be
available to the operator during every procedure.
CAUTION: If used correctly, embolizations caused by material detached by the catheter head are very rare.Under certain circumstances,
especially if any embolization would cause severe damage to the patient, it can be indicated to take appropriate measures for embolic
protection prior to the use of a Straub rotational catheter.
3. To determine the target vessel diameter, assess by suitable methods the narrowest nominal vessel diameter within the vessel segment to be
treated. Select the Aspirex
above) and in the suitable length to reach the target lesion. The Aspirex
WARNING: Do not use the Straub Mechanical Thrombectomy System if the patient's baseline clinical status is unsuitable.
11121 A1
®
S catheter in the French size appropriate to fit this target vessel diameter (see technical details and specifications
EN
Instruction For Use
®
S catheters.
®
S catheters are supplied in sets containing other necessary materials.
© Straub Medical AG
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