Ambu aScope 5 Cysto HD Mode D'emploi page 4

1. Important information – Read before use
In this document the term aScope 5 Cysto HD refers to Ambu® aScope™ 5 Cysto HD.
Read these instructions for use carefully before using aScope 5 Cysto HD. The Instructions for
Use may be updated without notice. Copies of the current version are available upon request.
Please be aware that these instructions do not explain or discuss clinical procedures.
Before initial use of the endoscope, it is essential for operators to have received sufficient
training in clinical endoscopic techniques and to be familiar with the intended use, indications,
warnings, cautions, and contraindications mentioned in these instructions.
aScope 5 Cysto HD is not covered by a warranty.
In this document "aScope 5 Cysto HD" refers to instructions which apply to the cystoscope
only and "aScope 5 Cysto HD system" refers to information relevant to aScope 5 Cysto HD,
compatible Ambu displaying units and accessories. Unless otherwise specified, endoscope
refers to all aScope 5 Cysto HD variants.
1.1. Intended use
aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for
endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to
provide visualization via a compatible Ambu displaying unit and can be used with endoscopic
accessories and instruments.
1.1.1. Intended patient population
aScope 5 Cysto HD is designed for use in adults requiring cystoscopy.
1.1.2. Intended use environment
aScope 5 Cysto HD is designed for use in a hospital environment or medical office environment.
1.2. Indications for use
aScope 5 Cysto HD is used in patients with disease in the lower urinary tract that requires
visualization and examination with a flexible cystoscope and the use of endoscopic accessories
and instruments.
1.3. Intended user
aScope 5 Cysto HD is for use by healthcare professionals: medical doctors, urologists, surgeons,
or nurses under medical responsibility trained within cystoscopy procedures.
1.4. Contraindications
No contraindications are identified for aScope 5 Cysto HD.
1.5. Clinical benefits
Together with the compatible Ambu displaying unit, aScope 5 Cysto HD provides endoscopic
access and visualization, enabling cystoscopic examination and procedures in the lower
urinary tract.
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