Contraindications; Warnings And Cautions - Ambu aScope 4 Cysto Mode D'emploi

1. Important information – Read before use
Read these safety instructions carefully before using the aScope 4 Cysto. The Instruction for use
may be updated without further notice. Copies of the current version are available upon request.
Please be aware that these instructions do not explain or discuss clinical procedures. They
describe only the basic operation and precautions related to the use of the aScope 4 Cysto.
Before initial use of the aScope 4 Cysto, it is essential for operators to have received sufficient
training in clinical endoscopic techniques and to be familiar with the intended use, warnings and
cautions described in these instructions.
There is no warranty on the aScope 4 Cysto.
In this document "aScope 4 Cysto" refers to instructions which applies to the cystoscope
only and "aScope 4 Cysto system" refers to information relevant for the aScope 4 Cysto,
Ambu displaying units, and accessories.
1.1. Intended use / Indication for use
The aScope 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for
endoscopic access to and examination of the lower urinary tract. The aScope 4 Cysto is intended
to provide visualization via the reusable Ambu Displaying Unit and can be used with endoscopic
accessories and instruments.
The aScope 4 Cysto is intended for use in a hospital environment or medical office environment.
The aScope 4 Cysto is designed for use for adult patients requiring cystoscopy.
1.2. Contra-indications
• 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.

1.3. Warnings and cautions

WARNINGS
1. Do not use the aScope 4 Cysto if the Inspection and Preparation of the aScope 4 Cysto
fails as it can cause patient injury.
2. Do not attempt to clean and reuse the aScope 4 Cysto as it is a single use device.
Reuse of the product can cause contamination leading to infections.
3. The distal end of the aScope 4 Cysto may get warm due to heating from the light
emission part. Avoid long periods of contact between the distal end of the aScope 4
Cysto and the mucosal membrane as sustained contact with the mucosal membrane
may cause mucosal injury.
4. aScope 4 Cysto camera images must not be used as an independent diagnostic of any
pathology. Doing so may result in incorrect or missing diagnosis. Physicians must
interpret and substantiate any findings by other means and in the light of the patient's
clinical characteristics.
5. Do not withdraw aScope 4 Cysto if an endoscopic instrument is protruding from the distal
end of the working channel as this can damage the urethral mucosa.
6. Do not activate an energised endoscopic instrument (e.g. laser equipment,
electrosurgical equipment) in the aScope 4 Cysto before the distal end of the instrument
can be seen in the image on the displaying unit as this can lead to patient injury or
damage aScope 4 Cysto.
7. Do not damage the insertion portion during use as it may leave parts of the product
inside the patient, or expose sharp surfaces that may cause damage to mucosa. Care
should be taken to avoid damaging the insertion portion when using aScope 4 Cysto with
endoscopic instruments.
8. Always watch the live image on the displaying unit when inserting or withdrawing the
aScope 4 Cysto or operating the bending section. Looking at a recorded image may
result in damage to mucosa or tissue.
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