Ambu aScope 5 Broncho 4.2 Mode D'emploi page 6

25. 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.
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 may lead to too high patient leakage current and
patient injury.
28. 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. Failure to do so may result in patient or user injury.
29. 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.
30. Do not use laser or high frequency endotherapy instruments (such as APC probe, hot
snare, hot forceps, etc) with aScope 5 Broncho 4.2/2.2 as it is not compatible. Failure to
comply may 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 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 and use, as liquids entering the
endoscope handle may cause camera malfunction.
6. Do not use a knife or other sharp instrument to open the pouch or cardboard box,
as this may lead to sharp edges on product or product malfunction.
7. Do not remove the suction button for any reason as this may 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 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,
dyspnoea, sore throat, apnoea, seizure, desaturation/hypoxemia, epistaxis, haemoptysis,
pneumothorax, aspiration pneumonia, pulmonary oedema, 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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