ROCAMED X-Filter Sterile Device Instructions

: June 9, 2024
: ROCAMED

Table of Contents

Description
Intended Use
Contraindications
Target Population
Potential Complications
Precautions
- Prior to use
Instructions For Use
Transport and storage conditions
Product Scrapping
Liability and Warranty
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Customer Support
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**ROCAMED X-Filter Sterile Device

**

Please read all instructions before using this device

Description

The X-Filter™ is sterile and for single use. Refer to the labelling for the device dimensions and/or specifications.
This device is made of a guidewire portion, and an expandable nitinol filter, to be deployed in the ureter to avoid migration of stone fragments towards kidney during a lithotripsy procedure. This device is not made with natural rubber latex.

Intended Use

The X-Filter device is intended for stone bypass and prevention of stone migration towards the kidney during ISWL procedures. Procedures involving removal of stones – impacted or otherwise –may benefit from the introduction of X-Filter device as complementary to the current ISWL procedure.

Contraindications

Not intended for use in the kidney.
Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Target Population

Device intended for adults only

Potential Complications

Trauma, perforation, entrapment, edema and complications associated with surgical interventions and endourological procedures.

Warnings

Do not use the device if damage to the sterile barrier is suspected.
Do not use the device if it has reached or passed its use by date.
Physician should be thoroughly qualified in endoscopic techniques for using this device.
For single use only; resterilization and/ or reuse of this product can lead to product dysfunction, cross-contamination, injury, illness or death. The manufacturer will not be held liable in the case of re-use / resterilization.
Avoid contact with any electrified instrument.

Precautions

Prior to the procedure, manoeuvre the device to ensure proper function.
Open and close the filter, do not use extractor if any damage is suspected.
The device must be handled carefully.
Insert/withdraw the device with caution. Stop immediately in case of anomaly or excessive resistance. Determine and eliminate the causes of the anomaly before continuing.
Do not attempt moving the device within the ureter once the filter has been deployed. Instead, if required, the filter may be retracted into the overlay tube allowing device repositioning inside the ureter.
The X-FILTER device is packed within a dispenser hoop in a sterile pouch. Using excessive force to deploy the device from its dispenser or afterwards may damage the device.

Prior to use

Remove the device from its sterilized pouch.
Attach a syringe filled with saline to the luer-lock port of the dispenser hoop.
Inject sufficient liquid to entirely wet device tip surface.

Instructions For Use

Fix the handle to the core wire to facilitate product manipulation.
Under fluoroscopic control, insert the device beyond the stone prior to deployment of the filter. The correct location suitable for deploying the filter is when the junction between the overlay tube and the tip (tip and overlay tube have different level of radiopacity) has passed the stone and is at least 10mm beyond it.
Deploy the filter by advancing the core wire while holding the overlay tube in place. Carefully move the core wire forward until the filter is fully expended, and the overlay tube has reached the stopper on the core wire.
The filter should be located at-least 10mm above the stone.
NOTE: Use extreme caution when using the device and a laser fiber; a laser can easily damage the device. Never apply direct laser beam to the filter or any other device part.
Try to avoid pushing or twisting of the core wire when the filter is in place.
Upon procedure completion, the filter can be retracted into the overlay tube. This is performed by pulling the core wire backwards while securing the overlay tube in place.
NOTE: if retracting the filter into the overlay tube is not smooth enough, it may be necessary to slightly advance the core wire to allow the release of any stone fragments that might be interrupting the filter retraction. Do not apply excessive force if resistance appears during filter retrieval into the overlay tube.
Check the intergrity of the device after withdrawal

Transport and storage conditions

The device should be stored and transported in a normal environment, i.e. away from extreme temperatures and humidity.

Product Scrapping

Destroy after use according to the regulations in force regarding disposal of potentially infectious waste material.

Liability and Warranty

ROCAMED and its affiliates warrants to the first purchaser of this device that reasonable care has been exercised in the design and manufacturing of this device. If any suspected damage is found, please call ROCAMED and its affiliated companies. This limited product warranty is in place of all other warranties, whether express or implies, including but not limited to any implied warranty of merchantability or fitness for a particular purpose. The responsibility of ROCAMED and its affiliates under this device warranty will be limited to replacement of defective device. Under no circumstance will ROCAMED and its affiliates be liable for any indirect, incidental or consequential damages resulting from the handling or use of this device.

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| Catalog number
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| Manufacturer
| CE mark
| Expiry Date
| Caution
| Batch/Lot Number
****| Consult Instructions for Use
| Sterilized using ethylene oxide
| Do not use if package is damaged
| Keep Away from Sunlight
| Keep Dry
| Do Not Reuse
| Do Not Resterilize;