Ambu aScope 4 Broncho Large, Instructions For Use Manual

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4. Do not exert excessive force on the bending section as this may result in damage to
the equipment. Examples of inappropriate handling of the bending section include:
– Manual twisting.
– Operating it inside an ETT 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. US federal law restricts these devices for sale only by, or on the order of, a physician.
6. Keep the endoscope handle dry during preparation, use and storage.
7. Do not use a knife or other sharp instrument to open the pouch or cardboard box.
8. Secure the tubing properly on the suction connector before suction is applied.
9. If needed remove secretion or blood from the airway before and during the
procedure. The suction function of any appropriate suction device can be used for
this purpose.
10. Apply a vacuum of 85 kPa (638 mmHg) or less when suctioning. Applying too large a
vacuum may make it difficult to terminate suctioning.
11. For single use only. Use on other patients can cause cross contamination. Do not soak,
rinse, or sterilize this device as these procedures may leave harmful residues or cause
malfunction of the device.
1.5. 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, reaction to drug or topical
anaesthesia, fever/infection, and respiratory/cardiac arrest.
1.6. 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.
2. System description
The aScope 4 Broncho can be connected to the Ambu displaying unit. For information about
the Ambu displaying unit, please refer to the displaying unit
Instruction for use .
2.1. System parts
Ambu® aScope™ 4 Broncho Sampler Set -
Single use device: Part numbers:
477501000 aScope 4 Broncho Regular
Sampler Set 5.0/2.2
478501000 aScope 4 Broncho Large
Sampler Set 5.8/2.8
aScope 4 Broncho Regular Sampler Set and aScope 4 Broncho Large Sampler Set are not
available in all countries. Please contact your local sales office.