Ambu 624001000US Gebruiksaanwijzing - Pagina 13

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Do not open the tip of the endotherapy instrument or extend the tip of the endotherapy

instrument from its sheath while the instrument is in the working channel, as this may damage

both the endotherapy instrument and the endoscope.

Insertion of active endotherapy instruments 7d

Use of active endotherapy instruments should always be operated according to the respective

manufacturer's instructions for use. Users shall always be familiar with safety precautions and

guidelines on the proper use of active endotherapy instruments, including use of adequate

personal protective equipment.

Do not activate an endotherapy instrument in the working channel before the instrument

distal end can be seen in the image.

It should be recognized that the use of active endotherapy instruments may interfere with

the normal endoscopic image and this interference is not indicative of a malfunction of

the endoscopic system. A variety of factors can affect the quality of the endoscopic image

during use of active endotherapy instruments. Factors such as intensity, high power setting,

close distance of the instrument probe to the endoscope tip and excessive tissue burning

can each adversely influence image quality.

Withdrawal of the endoscope 8

When withdrawing the endoscope, make sure that the control lever is in the neutral position.

Slowly withdraw the endoscope while watching the live endoscopic image.

4.3. After use

Visual check 9

1. Are there any missing parts on the bending section, lens, or insertion cord? If yes, then take

corrective action to locate the missing part(s).

2. Is there any evidence of damage on the bending section, lens, or insertion cord? If yes,

then examine the integrity of the product and conclude if there are any missing parts.

3. Are there cuts, holes, sagging, swelling or other irregularities on the bending section,

lens, or insertion cord? If yes, then examine the product to conclude if there are any

missing parts.

In case of corrective actions needed (step 1 to 3) act according to local hospital procedures.

Disconnect

Disconnect the endoscope from the displaying unit 10 . The aScope 5 Broncho is a single-use

device. Do not soak rinse, or sterilize this device as these procedures may leave harmful

residues or cause malfunction of the device. The design and materials used are not compatible

with conventional cleaning and sterilization procedures.

Disposal 11

The used aScope 5 Broncho is considered contaminated after use and must be disposed

of in accordance with local guidelines for collection of infected medical devices with

electronic components.

5. Technical product specifications

5.1. Standards applied

The endoscope 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.

– IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety

and essential performance – Collateral standard: Electromagnetic disturbances –

requirements and tests.