After Use; Standards Applied - Ambu aScope 4 Cysto Mode D'emploi

Aspiration and instillation of fluids 7
Aspiration might be required during the procedure. Prepare a syringe for this. When required,
attach the syringe to the aScope 4 Cysto and apply an aspiration force according to the wanted
effect. For larger quantity of fluid, disconnect the syringe from the cystoscope, empty the
syringe, and then reattach it to aspirate the remaining fluids.
Fluids e.g. sterile water or saline solution can be instilled through the working channel entry at
the bottom of the aScope 4 Cysto handle by connecting a syringe or infusion set with Luer
connection directly to the working channel entry or via a stopcock. If using a sterile water or
saline bag, make sure to place it so that potential spillage will not affect other equipment.
Insertion of endoscopic instruments 8
Always make sure to select the correct size endoscopic instrument for the aScope 4 Cysto
(see section 2.2.). Inspect the endoscopic instrument before using it. If there is any
irregularity in its operation or external appearance, replace it. Insert the endoscopic
instrument into the working channel entry and advance it carefully through the working
channel until it can be seen on the live image on the Ambu displaying unit.
Withdrawal of the aScope 4 Cysto 9
When withdrawing the aScope 4 Cysto, make sure that the control lever is in the neutral
position. Slowly withdraw the cystoscope while watching the live image on the displaying unit.

4.3. After use

Visual check 10
Check if there are any missing parts, evidence of damage, cuts, holes, sagging, or orther
irregularities on the bending section, distal end, or insertion cord of the aScope 4 Cysto. If yes,
then take corrective action to determine if any parts are missing and locate the missing part(s).
In case of corrective actions needed act according to local hospital procedures. The elements
of the insertion cord are visible in x-ray (radio opaque).
Final steps
Disconnect the aScope 4 Cysto from the Ambu displaying unit 11 .
1.
Dispose of the aScope 4 Cysto, which is a single-use device 12 . The aScope 4 Cysto is
2.
considered contaminated after use and must be disposed of in accordance with local
guidelines for collection of infected medical devices with electronic components.
The product design and materials used are not designed for reuse and cannot withstand
the reprocessing procedures used for reprocessing of endoscopes without the risk of
degrading and being contaminated.
5. Technical product specifications

5.1. Standards applied

The aScope 4 Cysto function conforms with:
– EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
– EN 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic equipment.
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