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1. Important information – Read before use
NOTE
Read these safety instructions carefully before using the Isiris Stent Removal Device.
The Instructions for use may be updated without further notice. Copies of the current
version are available upon request.
1.1. Instructions
The Isiris System is for use in hospital or in a medical office environment.
Isiris α is a sterile, single-use device designed for patients, accepting a scope diameter of
5.5 mm, implanted with a double loop ureteral stent, ranging from size CH4.8 to CH9.
Please be aware that these instructions do not explain or discuss clinical procedures.
They describe only the basic operations and precautions related to the operation of
the Isiris α. Before initial use of the Isiris α, it is essential for operators to have received
sufficient training in clinical cystoscopic techniques and to be familiar with the intended
use, warnings, cautions, notes, indications and contraindications mentioned in these
instructions.
1.2. Intended use
Isiris α 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 α has
been designed to be used with the reusable Isiris Monitor to visualize the observations
obtained by Isiris α.
1.3. Contraindications
•
Febrile patients with urinary tract infections (UTIs) or severe coagulopathy.
•
Patients with acute infection (acute urethritis, acute prostatitis, acute epididymitis).
•
Patients with known unpassable urethral stricture.
1.4. Warnings, cautions and notes
Appropriate warnings, cautions and notes are given describing potential safety hazards
associated with the use of the Isiris α. The information given in this instruction serves only
to instruct in the correct handling of the device.
WARNING
1.
Only to be used by trained physicians, trained in clinical endoscopic techniques
and procedures as incorrect use can cause harm to the patient.
2.
Images produced by the Isiris System must not be used as an independent
diagnostic tool of any pathology. Health care professionals must interpret and
substantiate any finding by other means and in the light of the patient's clinical
characteristics to avoid wrong diagnosis.
3.
Do not use the Isiris System for any other purpose than its intended use as it
may lead to patient harm.
4.
Discard the product if the Inspection and Preparation (section 4) of the product
fails as it can cause infection or patient injury.
5.
While withdrawing the scope, the distal tip must be in a neutral and non-
deflected position. Do not operate the bending lever, as this may result in injury
to the patient.
6.
Do not attempt to clean and reuse the Isiris α as it is a single use device.
Reuse of the product can cause contamination leading to infections,
major allergic reactions or patient injury.
7.
The Isiris System is neither MRI safe nor MRI compatible.
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02/06/2022 17:47
02/06/2022 17:47
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