ISIRIS® Stent Removal System
ISIRIS® is a single-use flexible cystoscope with an integrated grasper designed to make stent removals convenient. The scope’s image is displayed on the reusable ISIRIS® video monitor that includes an intuitive interface and recording capabilities. ISIRIS® eliminates the reprocessing burden of reusable scopes and permits stent removals to be done in lower-cost healthcare settings.
Remove ureteral stents conveniently
- Easy transport and quick set up
- No cumbersome cystoscopes and video towers needed
- Designed to save time and increase treatment capacity
- Reduces the reprocessing burden on reusable scopes
- Improved patient comfort by shortening indwelling time
- Reduction in delayed stent removal
- Clinician choice and opportunity to remove loop stents in almost any place at any time
|ISIRIS Stent Removal System|
|Item||Description||Sales UOM||EA / Sales UOM|
|ALFA01||Single-Use Isiris Devices||Retail Box||5 EA|
|MN0001||ISIRIS Monitor||Each||1 EA|
ISIRIS® Stent Removal Brief Statement
Isiris is a sterile single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via an urethral insertion in adults. Isiris has been designed to be used with the reusable Isiris monitor to visualize the observations obtained by Isiris.
Warnings and Precautions
Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the Isiris system, as this may result in patient injury or damage to the Isiris system. Alert the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the Isiris system. The Isiris system is neither MRI safe nor MRI compatible. Do not use the Isiris system during defibrillation. Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures. Passive deflection and retrovision maneuvers may be hazardous as it may affect the device, especially the grasper functionality. The distal end of the endoscope may get warm due to heating from the light emission part. Avoid long periods of contact between the tip of the device and the mucosal membrane as long, sustained contact with the mucosal membrane may cause mucosal injury. Do not enter any part of Isiris into the ureter. Do not activate the grasper when the distal end is inside the urethra. Do not activate the grasper during suctioning. Do not attempt to clean and reuse Isiris as it is a single-use device. Reuse of the product can cause contamination, leading to infections.
The risks and benefits of using ISIRIS® stent removal should be considered in patients.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.