ページを印刷する
1. Warning, Precautions and Notes
Please read the manual and follow the instructions carefully. Throughout these instructions, appropriate warnings, precautions and notes are given
describing potential safety hazards associated with use of the Ambu® aScope™ system.
KEY WARNINGS
• Do not use the Ambu® aScope™ system if any parts are damaged.
• Do not use the Ambu® aScope™ system during defibrillation.
• Do not attempt to clean and reuse the Ambu® aScope™ as it is a single patient use device.
• Do not use if the product sterilisation barrier or its packaging is damaged.
• The system is not to be used when delivering highly flammable anaesthetic gasses to the patient such as a Cyclopropane. This could potentially cause
patient injury
• The Ambu® aScope™ system is neither MRI safe nor MRI compatible.
• Perform a functional check before using the Ambu® aScope™ system. Failure to pass any of the tests indicate that the Ambu® aScope™ system should
not be used (see section 11).
• The Luer channel is only to be used for topical anaesthesia. Do not insert instruments, brushes etc. through the Luer channel as this may cause injury
to the patient or damage the Ambu® aScope™. Do not use the Luer channel for oxygen, suction etc.
• In case of massive bleeding in the airway do not use Ambu® aScope™.
• Total lifetime of the Ambu® aScope™ is 8 hours from first switching on.
• Operating time of the Ambu® aScope™ is 30 minutes from switching on. Pay attention to the red symbol (less than 5 minutes left) on the Ambu®
aScope™ Monitor (see section 8.2.1).
WARNING
• The Ambu® aScope™ system is to be used only with patients who have been clinically evaluated by a physician as suitable for endotracheal
intubation.
• To avoid potential patient injury the bending section and the distal tip must be placed in a neutral and non-angled position before the Ambu®
aScope™ is removed from the patient.
• If a malfunction should occur during intubation, stop the procedure immediately, put the distal tip in its neutral and non-angled position and slowly
retract the Ambu® aScope™.
• Do not use the Ambu® aScope™ system if there are any loose parts or the bending section does not work as intended.
• Do not touch the distal tip of the insertion cord or allow it to strike other objects. The lens surface of the distal tip is fragile and visual distortion may
occur.
• The Ambu® aScope™ system consists of the parts described in section 3. No other parts must be used.
• If the bending mechanism or any other part of the Ambu® aScope™ system is not functioning properly, stop the procedure immediately.
• Excessive force should never be used.
• Pay attention to the battery symbol indicator on the Ambu® aScope™ Monitor. Recharge the Ambu® aScope™ Monitor when the green battery
symbol changes to orange (see section 8.2.1).
• After the system has been used, refer to the Ambu® aScope™ post-check instructions before placing in a waste container.
• The Ambu® aScope™ contains static-sensitive components. Handling precautions required.
PRECAUTIONS
• US federal law restricts these devices for sale only by, or on the order of, a physician.
• Have spare parts ready and prepared for immediate use.
• Keep the Ambu® aScope™ handle and the Ambu® aScope™ monitor dry.
• Patients should be adequately monitored at all times during use.
• Make sure that the Ambu® aScope™ Monitor is fully charged before commencing the procedure.
• It is recommended that a mouthpiece is placed in the patient's mouth to protect the Ambu® aScope™.
• To minimize contamination, always wear gloves during preparation and intubation, and avoid contact with any unclean objects.
• Do not manually twist or bend the bending section. Adjust only by operating the control lever, otherwise damage may result.
• Clean the Ambu® aScope™ Monitor after each use.
• Disconnect the Ambu® aScope™ Monitor from any mains power supply before cleaning.
• Place or hang the Ambu® aScope™ Monitor on a stable support during installation. Dropping it could cause damage.
• Position the power cord so that people cannot step on it. Do not place anything over the power cord.
• Do not use a knife or other sharp instrument to open the pouch or cardboard box.
• Only use the power supply that is supplied with the Ambu® aScope™ Monitor, part number 4 in section 3.
• If needed remove secretion or blood from the airway before and during the procedure. Appropriate suction device or other standard procedures can
be used for this purpose.
4