Ambu aScope 5 Broncho Bedienungsanleitung Seite 6

25. The user must use their professional judgment when deciding whether a bronchoscopy
procedure will be appropriate for patients with severe heart disease (e.g. life-threatening
arrhythmia and recent myocardial infarction) or acute respiratory failure with hypercapnia.
Uncorrected coagulopathy is relevant if transbronchial biopsy is planned. There is
a higher rate of serious complications in the mentioned categories of patients.
26. Use of endotherapy instruments, including cryo probe, may, in rare, cases cause gas
embolism. Monitor the patient appropriately during and after treatment.
27. Patient leakage currents may be additive when using active endotherapy instruments.
Active endotherapy instruments must be classified as "type CF" or "type BF" according
to IEC 60601. Failure to comply could lead to patient leakage current that is too high
and patient injury.
28. Endotherapy instruments must always be operated according to the respective
manufacturer's Instructions for Use. Users must always be familiar with safety precautions
and guidelines on the proper use of endotherapy instruments, including use of adequate
personal protective equipment. Failure to do so could result in patient or user injury.
29. Always operate the endoscope and display unit as specified in the Instructions for Use
for each product. Failure to do so could result in patient or user injury.
30. Do not use laser or high frequency endotherapy instruments (such as APC probe,
hot snare, hot forceps, etc) with aScope 5 Broncho 2.7/1.2 and 4.2/2.2, as it is not
compatible. Failure to comply could result in patient injury.
CAUTIONS
1. Have a suitable backup system readily available for immediate use so the procedure
can be continued if a malfunction were to occur.
2. Be careful not to damage the endoscope when used with sharp endotherapy instruments
such as needles.
3. Be careful when handling the distal tip and do not allow it to strike other objects,
as this could result in damage to the endoscope. The lens surface of the distal tip is
fragile and visual distortion may occur.
4. Do not exert excessive force on the bending section, as this could result in damage to
the endoscope. Examples of inappropriate handling of the bending section include:
– Manual twisting.
– Operating it inside an ET tube or in any other case where resistance is felt.
– Inserting it into a preshaped tube or a tracheostomy tube with the bending direction
not aligned with the curve of the tube.
5. Keep the endoscope handle dry during preparation and use, as liquids entering the
endoscope handle could cause camera malfunction.
6. Do not use a knife or other sharp instrument to open the pouch or cardboard box,
as this could result in sharp edges on the product or product malfunction.
7. Do not remove the suction button for any reason, as this could result in damage to
the endoscope and loss of suction.
8. Only use the endoscope with medical electrical equipment that complies with IEC 60601-1,
any associated applicable collateral and particular standards, or equivalent safety
standards. Failure to do so could result in equipment damage.
1.6. Potential adverse events
Potential adverse events in relation to flexible bronchoscopy (not exhaustive): Tachycardia,
bradycardia, hypotension, bleeding, bronchospasm/laryngospasm, cough, dyspnea, sore throat,
apnea, seizure, desaturation/hypoxemia, epistaxis, hemoptysis, pneumothorax, aspiration
pneumonia, pulmonary edema, airway obstruction, fever/infection, and respiratory/cardiac arrest.
1.7. General notes
If a serious incident has occurred while using this device or as a result of its use, please report it
to the manufacturer and to your national authority.
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