Intersurgical i-view Gebrauchsanweisung Seite 4

The medical device is not supplied individually. Only one copy of the instructions for use is provided per box
and should therefore be kept in an accessible location for all users. More copies available upon request.
NOTE: Distribute instructions to all product locations and users.
These instructions contain important information for the safe use of the product. Read these instructions
for use in their entirety, including warnings and cautions before using this product. Serious incidents to be
reported as per the local regulation.
WARNING: A WARNING statement provides important information about a potentially hazardous situation
which, if not avoided, could result in death or serious injury.
CAUTION: A CAUTION statement provides important information about a potentially hazardous situation
which, if not avoided, could result in minor or moderate injury.
Description
• The Intersurgical i-view™ is a single use, hand-held fully disposable video laryngoscope, suitable for
use with adult patients to facilitate oral tracheal intubation, including during anaesthesia and emergency
medicine.
Intended use
To facilitate laryngoscopy.
Warnings
• For use by qualified medical personnel only. Operators must familiarise themselves with these instructions
for use, and the device.
• No modification of this device is permitted.
• The device contains no user serviceable parts inside.
• The batteries within the device should not be removed prior to its disposal.
• No attempt should be made to reprocess, sterilise or re-use the device.
• Do not use force to insert the device.
• Particular care should be taken with patients who have fragile and vulnerable dental work, in accordance
with recognised airway management practices and techniques.
• In circumstances where fogging is regarded as a possiblity, such as when the patient is exposed to high
flow humidified oxygen before or during use of the i-view, the device should be turned on > 30 seconds
prior to use.
• To reduce the potential for trauma, the i-view should always be inserted into the patient's mouth under
direct vision.
• To reduce the potential for trauma, the endotracheal tube should always be initially introduced into the
patient's mouth under direct vision. The endotracheal tube may then be advanced through the vocal cords
by direct or indirect vision.
• Ensure that a backup plan is in place in case of difficulty or emergency while performing the procedure.
• Do not use the device in strong magnetic fields such as MRI environments.
• Users should use both direct and indirect (video) visualisation to progressively expose the key anatomical
landmarks in accordance with best practice for laryngoscopy.
• When turning off the device, the on/off button should be depressed for more than half a second.
• During prolonged use, the clear lens in front of the light source can reach temperatures up to a maximum
of 50°C and should not be held in direct contact with patient tissue for longer than 1 minute.
Indications For Use
i-view is designed to provide direct and indirect visualisation of the larynx. It helps to facilitate oral tracheal
intubation in adults by personnel who are suitably trained and experienced in the use of airway management
techniques and devices, including intubation. i-view is approved for use in road ambulances under
IEC 60601-1-12.
Contraindications
• Surgical airway.
• Fluid or solid material in the airway that cannot be cleared with suction.
• Trismus, limited mouth opening, pharyngo-perilaryngeal abscess, trauma or mass.
• Operator inexperience with the device.
Size Selection
• i-view is available in one size for adult patients. In smaller adult patients, it may not be necessary to insert
the blade as far as may be necessary for an average sized adult patient in order to gain an optimal view
of the relevant anatomical structures. For patients where the blade of the i-view is not large enough to
enable these structures to be viewed, an alternative device should be used.
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