Idiomas disponibles
Idiomas disponibles
26. The user must exercise professional judgement when deciding whether a bronchoscopy
procedure will be appropriate for patients with severe heart disease (e.g. life-threatening
arrythmia and recent myocardial infarction) or acute respiratory failure with hypercapnia.
Uncorrected coagulopathy is relevant if transbronchial biopsy is planned. Serious
complications have a higher rate in the mentioned categories of patients.
27. Use of endotherapy instruments including Argon Plasma Coagulation (APC) probe and
nd-YAG laser may in rare cases cause gas embolism. Monitor the patient appropriately
during and after treatment.
28. 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 may lead to too high patient leakage current and patient injury.
29. Endotherapy instruments shall 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 endotherapy instruments, including
use of adequate personal protective equipment e.g. wearing suitable protective
filtering spectacles when using laser equipment together with the endoscope.
Failure to do so may result in patient or user injury.
30. Always operate endoscope and displaying unit according to the instructions for use for
each product. Failure to do so may result in patient or user injury.
CAUTIONS
1. Have a suitable backup system readily available for immediate use so the procedure can
be continued if a malfunction should occur.
2. Be careful not to damage the endoscope in combination 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
may 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 may 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, use and storage.
6. Do not use a knife or other sharp instrument to open the pouch or cardboard box.
7. Using electrosurgical equipment with aScope 5 Broncho HD may disturb the image on
the displaying unit and/or external monitor.
8. Do not remove the suction button for any reason as this may result in damage to the
endoscope and loss of suction.
9. US federal law restricts this device to sale by or on the order of a licensed health
care practitioner.
10. 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 may lead to 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, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
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