After Use; Standards Applied - Ambu aScope 4 RhinoLaryngo Intervention Instrucciones De Uso

Insertion of the endoscope 7a
To ensure the lowest possible friction during insertion of the endoscope the insertion cord
may be lubricated with a medical grade lubricant. If the images of the endoscope becomes
unclear, clean the tip. When inserting the endoscope orally, it is recommended to use a
mouthpiece to protect the scope from being damaged.
Instillation of fluids 7b
Insert a syringe into the working channel at the top of the endoscope to inject fluids. When
using a Luer Lock syringe, use the included introducer. Insert the syringe completely into the
working channel port or the introducer and press the plunger to inject fluid. Make sure suction
is not applied during this process, as this will direct the injected fluids into the suction collection
system. To ensure that all fluid has left the channel, flush the channel with 2 ml of air.
Aspiration 7c
When a suction system is connected to the suction connector, suction can be applied by
pressing the suction button with the index finger. If the introducer and/or an endoscopic
accessory is placed inside the working channel note that the suction capability will be
reduced. For optimal suction capability it is recommended to remove the introducer or
syringe entirely during suction.
Insertion of endoscopic accessories 7d
Always make sure to select the correct size endoscopic accessory for the endoscope
(See section 5.2). Inspect the endoscopic accessory before using it. If there is any irregularity
in its operation or external appearance, replace it. Insert the endoscopic accessory into the
working channel port and advance it carefully through the working channel until it can be
seen on the live image on the monitor. The enclosed introducer can be used to facilitate the
insertion of soft accessories.
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 image on the monitor.

4.5. After Use

Visual check 9
Inspect the endoscope for any evidence of damage on the bending section, lens, or insertion
cord. In case of corrective actions needed based on the inspection act according to local
hospital procedures.
Final steps 10
Disconnect the endoscope from the Ambu monitor and dispose the endoscope in accordance
with local guidelines for collection of infected medical devices with electronic components.
5. Technical Product Specifications

5.1. Standards Applied

The endoscope function conforms with:
– IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
– IEC 60601-1-2: Medical electrical equipment – Part 1-2 General requirements for safety –
Collateral standard: Electromagnetic compatibility - Requirements for test.
– IEC 60601-2-18: Medical electrical equipment – Part 2-18: Particular requirements for the
safety of endoscopic equipment.
– ISO 8600-1: Optics and photonics - Medical endoscopes and endotherapy devices – Part 1:
General requirements.
– ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within
a risk management process.
– ISO 594-1: Conical fittings with 6% (Luer) taper for syringes, needles and certain other
medical equipment – Part 1: General requirements.
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